Rheumatoid Arthritis Extension Trial For Subjects Who Hav... | NCT01643928 | Trialant
NCT01643928
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 29, 2019Actual
Enrollment
185Actual
Phase
Not Applicable
Conditions
Rheumatoid Arthritis
Interventions
Rituximab-Pfizer (PF-05280586) x 3 courses
Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Rituximab-US + Rituximab-Pfizer x 2 Courses
Countries
United States
Australia
Canada
Colombia
Germany
Israel
Mexico
Russia
South Africa
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01643928
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B3281004
Secondary IDs
ID
Type
Description
Link
ICON 9002/0101
2012-003223-38
EudraCT Number
Brief Title
Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
Official Title
EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 16, 2012Actual
Primary Completion Date
Mar 14, 2016Actual
Completion Date
Mar 14, 2016Actual
First Submitted Date
Jul 6, 2012
First Submission Date that Met QC Criteria
Jul 16, 2012
First Posted Date
Jul 18, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 23, 2017
Results First Submitted that Met QC Criteria
May 9, 2017
Results First Posted Date
Jun 8, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 8, 2019
Last Update Posted Date
Jan 29, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
extension trial
rheumatoid arthritis
rituximab
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
185Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Rituximab-Pfizer
Experimental
Biological: Rituximab-Pfizer (PF-05280586) x 3 courses
Rituximab-EU+Rituximab-Pfizer
Active Comparator
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Rituximab-US+Rituximab-Pfizer
Active Comparator
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.
Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Rituximab-Pfizer (PF-05280586) x 3 courses
Biological
1000 mg intravenous infusion [IV] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
Rituximab-Pfizer
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay
Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb.
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.
Exclusion Criteria:
Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
Cohen SB, Burgos-Vargas R, Emery P, Jin B, Cronenberger C, Vazquez-Abad MD. Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1598-1606. doi: 10.1002/acr.23586.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Participants given PF-05280586 in Study B3281001 received PF-05280586. Participants given licensed product in Study B3281001 received the same licensed product or PF-05280586 in Course 1. All participants received PF-05280586 in later courses. 185 participants were randomized to Study B3281004, 183 participants received study treatment.
Recruitment Details
This was an extension study for participants with active rheumatoid arthritis who had participated for at least 16 weeks in a prior rituximab-Pfizer protocol (B3281001) and had not received intervening treatment with investigational agents or other biologics (including Rituxan and MabThera).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PF-05280586/PF-05280586/PF-05280586
This group received intravenous (IV) rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Switzerland
Ukraine
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Biological
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Rituximab-EU+Rituximab-Pfizer
Rituximab-US + Rituximab-Pfizer x 2 Courses
Biological
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Rituximab-US+Rituximab-Pfizer
Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay
Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb.
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Mean Rituximab Serum Trough Concentrations
Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).
Cluster of Differentiation 19 (CD19+) B Cell Count
Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.
Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.
Circulating Immunoglobulin G (IgG) Concentrations
Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Circulating Immunoglobulin M (IgM) Concentrations
Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Circulating Rheumatoid Factor (RF) Concentrations
RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.
Week 1 and 25 (Course 1, Course 2, and Course 3).
Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement
Blood samples were obtained to determine anti-CCP and compliment levels in serum.
Week 1 and 25 (Course 1, Course 2, and Course 3).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Week 1, 6, 13, and 25 (Course 1).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Outcome Measure Using HAQ-DI - by the End of Course 1
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Week 1, 6, 13, and 25 (Course 1).
Outcome Measure Using HAQ-DI - by the End of Course 2
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Week 1, 6, 13, and 25 (Course 1 and Course 2).
Outcome Measure Using HAQ-DI - by the End of Course 3
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Huntsville
Alabama
35801
United States
Arthrocare, Arthritiscare & Research, PC
Gilbert
Arizona
85234
United States
CHI St. Vincent Medical Group Hot Springs
Hot Springs
Arkansas
71913
United States
UCLA Clinical & Translational Research Center
Los Angeles
California
90095
United States
UCLA David Geffen School of Medicine
Los Angeles
California
90095
United States
Desert Medical Advances
Palm Desert
California
92260
United States
New England Research Associates, LLC
Trumbull
Connecticut
06611
United States
QPS Labs
Newark
Delaware
19711
United States
University of South Florida - College of Medicine Carol and Frank Morsani Center
Tampa
Florida
33612
United States
Loyola University Medical Center
Maywood
Illinois
60153
United States
Illnois Bone & Joint Institute
Morton Grove
Illinois
60053
United States
Covance Central Laboratory Services
Indianapolis
Indiana
46214
United States
Bluegrass Community Research, Inc.
Lexington
Kentucky
40504
United States
Klein & Associates, M.D., P.A.
Cumberland
Maryland
21502
United States
Clinical Pharmacology Study Group
Worcester
Massachusetts
01605
United States
Bronson Internal Medicine and Rheumatology
Battle Creek
Michigan
49015
United States
Justus J. Fiechtner, MD, PC
Lansing
Michigan
48910
United States
University of Nevada School of Medicine
Las Vegas
Nevada
89102
United States
Dartmouth - Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical
Great Neck
New York
11021
United States
PMG Research of Hickory LLC
Hickory
North Carolina
28602
United States
PMG Research of Hickory, LLC
Hickory
North Carolina
28602
United States
Cincinnati Rheumatic Disease Study Group
Cincinnati
Ohio
45219
United States
Health Research of Oklahoma
Oklahoma City
Oklahoma
73103
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
The Arthritis Group
Philadelphia
Pennsylvania
19152
United States
Clinical Research Center of Reading, LLC
Wyomissing
Pennsylvania
19610
United States
Arthritis Associates, PLLC
Hixson
Tennessee
37343
United States
Arthritis Clinic
Jackson
Tennessee
38305
United States
West Tennessee Research Institute
Jackson
Tennessee
38305
United States
Metroplex Clinical Research Center
Dallas
Texas
75231
United States
Apocell, Inc
Houston
Texas
77054
United States
Southwest Rheumatology Research, LLC
Mesquite
Texas
75150
United States
Rheumatology Research Unit
Maroochydore
Queensland
4558
Australia
Pharmacie Matte et Petit
Québec
Quebec
G1V 3M7
Canada
Centre de Recherche Saint-Louis
Québec
Quebec
G1W 4R4
Canada
Clinique Medicale du Phare (ECG Only)
Rimouski
Quebec
G5L 1J5
Canada
Centre de Rhumatologie de l'Est du Quebec
Rimouski
Quebec
G5L 8W1
Canada
Clínica Medellín S.A. Sede Centro
Medellín
Antioquia
Colombia
IPS Rodrigo Botero S.A.S.
Medellín
Antioquia
Colombia
Mix Supplier S.A.
Medellín
Antioquia
Colombia
Rodrigo Botero S.A.S.
Medellín
Antioquia
Colombia
Centro de Reumatologia y Ortopedia
Barranquilla
Atlántico
Colombia
Clinica de La Costa Ltda.
Barranquilla
Atlántico
Colombia
Congregación de las Hermanas Franciscanas Misioneras de María Auxiliadora-Clinica La Asuncion
Barranquilla
Atlántico
Colombia
IPS Centro Integral de Reumatologia del Caribe, CIRCARIBE S.A.S.
Barranquilla
Atlántico
Colombia
IPS Centro Integral De Reumatologia del Caribe, CIRCARIBE S.A.S
Barranquilla
Atlántico
Colombia
Organizacion Clinica General Del Norte S.A.
Barranquilla
Atlántico
Colombia
Schlosspark-Klinik GmbH, Internal Medicine II
Berlin
14059
Germany
The Chaim Sheba Medical Center
Tel Litwinsky
5262000
Israel
Hospital Bernardette (Emergencies)
Guadalajara
Jalisco
44200
Mexico
Private Office
Guadalajara
Jalisco
44650
Mexico
C.T. Scanner de Mexico, S.A. de C.V. (CT ONLY)
Mexico City
Mexico City
06700
Mexico
CLIDITER, S.A de C.V.
Mexico City
Mexico City
06700
Mexico
Hospital Angeles Clinica Londres
Mexico City
Mexico City
06700
Mexico
Hospital Angeles, Centro Medico del Potosi
San Luis Potosí City
78200
Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
San Luis Potosí City
78213
Mexico
LLC Scientific and Research Medical Complex "Your Health"
Kazan'
Tatarstan Republic
420103
Russia
State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"
Kemerovo
650000
Russia
LLC Consulting and Diagnostic Rheumatological Center "Healthy Joints"
Novosibirsk
630099
Russia
St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital 25"
Saint Petersburg
190068
Russia
"AVA-PETER" Ltd - Affiliate Address
Saint Petersburg
191014
Russia
AVA-PETER Ltd.
Saint Petersburg
191014
Russia
Local Ethics Committee of LLC AVA-PETER
Saint Petersburg
191025
Russia
Laboratory of LLC AVA-PETER
Saint Petersburg
Russia
State Budget Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin
Samara
443095
Russia
State Institution of Healthcare "Samara Regional Clinical Hospital named after V.D. Seredavin"
Samara
443095
Russia
Panorama Medical Centre - Room 136
Cape Town
7500
South Africa
Dr. Jan Fourie Medical Centre
KwaZulu Natal
3000
South Africa
Division of Rheumatic & Musculoskeletal Diseases
Leeds
LS7 1NR
United Kingdom
FG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
FG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
FG003
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
FG004
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
FG00058 subjects
FG00132 subjects
FG00233 subjects
FG00330 subjects
FG00430 subjects
COMPLETED
FG00048 subjects
FG00130 subjects
FG00230 subjects
FG00327 subjects
FG00428 subjects
NOT COMPLETED
FG00010 subjects
FG0012 subjects
FG0023 subjects
FG0033 subjects
FG0042 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0005 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
BG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
BG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
BG003
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
BG004
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00058
BG00132
BG00233
BG00330
BG00430
BG005183
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00055.3± 12.01
BG00156.0± 11.88
BG00256.7± 9.35
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00050
BG00129
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
Modified intent-to-treat (mITT) population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.
Posted
Number
Percentage of Participants
Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-EU Total
Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG003
Title
Denominators
Categories
Total (C1) +ve
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG003
Primary
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
mITT population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.
Posted
Number
Percentage of Participants
Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
Primary
Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay
Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb.
mITT Population. Only participants with a positive ADA status were included in the analysis.
Posted
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
Primary
Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay
Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb.
mITT Population. Only participants with a positive ADA status were included in the analysis.
Posted
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
Primary
Mean Rituximab Serum Trough Concentrations
Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.
mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
Posted
Mean
Standard Deviation
nanograms per milliliter
Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
Primary
Cluster of Differentiation 19 (CD19+) B Cell Count
Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.
mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
Posted
Median
Full Range
cells per microliter
Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
Primary
Circulating Immunoglobulin G (IgG) Concentrations
Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.
mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
Posted
Mean
Standard Deviation
grams per liter (g/L)
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
Primary
Circulating Immunoglobulin M (IgM) Concentrations
Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.
mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
Posted
Mean
Standard Deviation
g/L
Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
Primary
Circulating Rheumatoid Factor (RF) Concentrations
RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.
mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
Posted
Mean
Standard Deviation
international units per milliliter
Week 1 and 25 (Course 1, Course 2, and Course 3).
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
Primary
Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement
Blood samples were obtained to determine anti-CCP and compliment levels in serum.
mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
Posted
Mean
Standard Deviation
U/mL
Week 1 and 25 (Course 1, Course 2, and Course 3).
ID
Title
Description
OG000
PF-05280586/PF-05280586/PF-05280586
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
Primary
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Mean
Standard Deviation
Units on a scale
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Mean
Standard Deviation
Units on a scale
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Mean
Standard Deviation
Units on a scale
Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
Primary
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
Primary
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Primary
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
Primary
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
Primary
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
Primary
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Number
Percentage of participants
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Number
Percentage of participants
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
Primary
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Number
Percentage of participants
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
Primary
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Number
Percentage of Participants
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Mean
Standard Deviation
Percent change in joint count
Screening, Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in joint count
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in joint count
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Mean
Standard Deviation
Percent change in joint count
Screening, Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in joint count
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in joint count
Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3
Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU: by the End of Course 1
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Mean
Standard Deviation
Percent change in score
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Outcome Measure Using HAQ-DI - by the End of Course 1
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
Posted
Mean
Standard Deviation
Score on a scale
Week 1, 6, 13, and 25 (Course 1).
ID
Title
Description
OG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Outcome Measure Using HAQ-DI - by the End of Course 2
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
Posted
Mean
Standard Deviation
Score on a scale
Week 1, 6, 13, and 25 (Course 1 and Course 2).
ID
Title
Description
OG000
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Primary
Outcome Measure Using HAQ-DI - by the End of Course 3
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.
Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.
Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
Posted
Mean
Standard Deviation
Score on a scale
Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
ID
Title
Description
OG000
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Time Frame
Serious adverse events (SAEs) were logged from informed consent until up to 28 calendar days after last study drug administration or Long Term Follow-Up, whichever was last. Adverse events (AEs) were logged from first dose of study drug to last visit.
Description
SAEs & AEs were summarized by course for events with first onset on or after the first dose of study drug in that course & before the first dose of in the subsequent course, or any pre-existing event that worsened in severity during that course. An event may appear twice as data is cumulative for participants who received treatment in Course 2 & 3.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
PF-05280586: by the End of Course 1
This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
4
58
18
58
EG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
2
32
3
32
EG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
2
33
8
33
EG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
1
30
15
30
EG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
2
30
7
30
EG005
PF-05280586: by the End of Course 2
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
6
54
26
54
EG006
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
1
30
15
30
EG007
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
4
31
13
31
EG008
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
2
29
18
29
EG009
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
1
29
10
29
EG010
PF-05280586: by the End of Course 3
This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
4
48
25
48
EG011
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
1
30
18
30
EG012
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
4
30
15
30
EG013
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
1
27
18
27
EG014
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
1
29
17
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0021 affected33 at risk
EG0030 affected30 at risk
EG0040 affected30 at risk
EG0050 affected54 at risk
EG0060 affected30 at risk
EG0071 affected31 at risk
EG0080 affected29 at risk
EG0090 affected29 at risk
EG0100 affected48 at risk
EG0110 affected30 at risk
EG0121 affected30 at risk
EG0130 affected27 at risk
EG0140 affected29 at risk
Febrile Neutropenia
Blood and lymphatic system disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Diaphragmatic Hernia
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Arthritis Infective
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0021 affected33 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0011 affected32 at risk
EG0020 affected33 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0011 affected32 at risk
EG0020 affected33 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Wound Infection Staphylococcal
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Syncope
Nervous system disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Blighted Ovum
Pregnancy, puerperium and perinatal conditions
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Arthritis Bacterial
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Transient Ischemic Attack
Nervous system disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0011 affected32 at risk
EG0020 affected33 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0021 affected33 at risk
EG0032 affected30 at risk
EG0042 affected30 at risk
EG0052 affected54 at risk
EG0061 affected30 at risk
EG0071 affected31 at risk
EG0083 affected29 at risk
EG0092 affected29 at risk
EG0101 affected48 at risk
EG0111 affected30 at risk
EG0121 affected30 at risk
EG0133 affected27 at risk
EG0142 affected29 at risk
Nausea
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0002 affected58 at risk
EG0010 affected32 at risk
EG0021 affected33 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0022 affected33 at risk
EG003
Asthenia
General disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Fatigue
General disorders
MedDRA 19.0
Non-systematic Assessment
EG0003 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0013 affected32 at risk
EG0021 affected33 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0004 affected58 at risk
EG0010 affected32 at risk
EG0021 affected33 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0021 affected33 at risk
EG003
Rheumatoid Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Non-systematic Assessment
EG0004 affected58 at risk
EG0011 affected32 at risk
EG0023 affected33 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0021 affected33 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Depression
Psychiatric disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0002 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0011 affected32 at risk
EG0020 affected33 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0002 affected58 at risk
EG0011 affected32 at risk
EG0020 affected33 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected58 at risk
EG0011 affected32 at risk
EG0021 affected33 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0011 affected32 at risk
EG0020 affected33 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0011 affected32 at risk
EG0020 affected33 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0011 affected32 at risk
EG0021 affected33 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Gastrointestinal Viral Infection
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0002 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0021 affected33 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected58 at risk
EG0010 affected32 at risk
EG0020 affected33 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo. Investigator will, on request, remove any previously undisclosed Confidential Information (other than the Study results themselves) before disclosure.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
2 subjects
52.6
± 13.73
BG00455.8± 10.35
BG00555.3± 11.55
23
BG00320
BG00425
BG005147
Male
BG0008
BG0013
BG00210
BG00310
BG0045
BG00536
OG004
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG005
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG006
Rituximab-US Total
Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
65
OG00430
OG00530
OG00660
64
ParticipantsOG00430
ParticipantsOG00530
ParticipantsOG00660
Title
Measurements
OG0003.5
OG0010.0
OG00215.2
OG0037.8
OG00413.3
OG0056.7
OG00610.0
Total (C2) +ve
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00361
ParticipantsOG00429
ParticipantsOG00529
ParticipantsOG00658
Title
Measurements
OG0005.7
OG0013.3
OG0020.0
OG003
Total (C3) +ve
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00360
ParticipantsOG00427
ParticipantsOG00529
ParticipantsOG00656
Title
Measurements
OG0002.1
OG0010.0
OG0020.0
OG003
C1 to C3 +ve
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00365
ParticipantsOG00430
ParticipantsOG00530
ParticipantsOG00660
Title
Measurements
OG0008.6
OG0013.1
OG00215.2
OG003
OG001
Rituximab-EU/PF-05280586/PF-05280586
This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-EU Total
Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
OG004
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG005
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG006
Rituximab-US Total
Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00365
OG00430
OG00530
OG00660
Title
Denominators
Categories
Total (C1) +ve
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00364
ParticipantsOG00430
ParticipantsOG00530
ParticipantsOG00660
Title
Measurements
OG0003.5
OG0013.2
OG00215.2
OG003
Total (C2) +ve
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00361
Total (C3) +ve
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00360
C1 to C3 +ve
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00365
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-EU Total
Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
OG004
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG005
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG006
Rituximab-US Total
Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-EU Total
Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
OG004
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG005
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG006
Rituximab-US Total
Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG004
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00051
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00428
Title
Measurements
OG000636.5± 816.33
OG001855.5± 1594.51
OG002416.6± 615.86
OG003
Course 1/Week 3
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00130
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 3
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00052
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG00110
ParticipantsOG00218
ParticipantsOG00314
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 3
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00325
Course 3/Week 25 (EOT)
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00328
Follow up-Month 3
ParticipantsOG00035
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00315
Follow up-Month 6
ParticipantsOG00029
ParticipantsOG00119
ParticipantsOG00215
ParticipantsOG0039
Follow up-Month 9
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Follow up-Month 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG004
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00049
ParticipantsOG00128
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00425
Title
Measurements
OG0000.0(0.0 to 109.2)
OG0011.1(0.0 to 105.6)
OG0020.6(0.0 to 55.9)
OG003
Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00329
Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00329
Course 1/Week 25
ParticipantsOG00034
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
Course 2/Week 1
ParticipantsOG00051
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00328
Course 2/Week 6
ParticipantsOG00049
ParticipantsOG00130
ParticipantsOG00228
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00050
ParticipantsOG00128
ParticipantsOG00229
ParticipantsOG00327
Course 2/Week 25
ParticipantsOG00027
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
Course 3/Week 1
ParticipantsOG00044
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00325
Course 3/Week 13
ParticipantsOG00043
ParticipantsOG00128
ParticipantsOG00228
ParticipantsOG00323
Course 3/Week 25 (EOT)
ParticipantsOG00049
ParticipantsOG00128
ParticipantsOG00230
ParticipantsOG00327
Follow up-month 3
ParticipantsOG00030
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG00313
Follow up-Month 6
ParticipantsOG00025
ParticipantsOG00118
ParticipantsOG00214
ParticipantsOG0037
Follow up-Month 9
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG004
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Screening
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00232
ParticipantsOG00329
ParticipantsOG00430
Title
Measurements
OG00011.7± 3.06
OG00110.9± 2.54
OG00211.6± 2.85
OG003
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG0019
ParticipantsOG00222
ParticipantsOG00313
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 25 (EOT)
ParticipantsOG00054
ParticipantsOG00131
ParticipantsOG00230
ParticipantsOG00329
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG004
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Screening
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00219
ParticipantsOG00322
ParticipantsOG00423
Title
Measurements
OG0001.0± 0.50
OG0011.1± 0.73
OG0021.1± 0.70
OG003
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 25 (EOT)
ParticipantsOG00054
ParticipantsOG00131
ParticipantsOG00230
ParticipantsOG00329
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG004
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00053
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00325
ParticipantsOG00429
Title
Measurements
OG000105.6± 203.88
OG001431.3± 1074.13
OG002128.7± 201.11
OG003
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 25 (EOT)
ParticipantsOG00055
ParticipantsOG00131
ParticipantsOG00230
ParticipantsOG00329
OG002
PF-05280586/PF-05280586/PF-05280586 (EU)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
OG003
Rituximab-US/PF-05280586/PF-05280586
This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
OG004
PF-05280586/PF-05280586/PF-05280586 (US)
This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00326
ParticipantsOG00428
Title
Measurements
OG000293.7± 206.64
OG001346.1± 206.78
OG002311.5± 198.13
OG003
Course 1/Week 25
ParticipantsOG00034
ParticipantsOG0019
ParticipantsOG00222
ParticipantsOG00311
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 25 (EOT)
ParticipantsOG00055
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Baseline B3281001
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG0005.59± 0.862
OG0015.81± 0.926
OG0025.80± 0.988
OG003
Change at Course 1/Week 1
ParticipantsOG00051
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00325
Change at Course 1/Week 6
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Change at Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00130
ParticipantsOG00233
ParticipantsOG00329
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Baseline B3281001
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG0005.59± 0.893
OG0015.81± 0.956
OG0025.77± 1.009
OG003
Change at Course 1/Week 1
ParticipantsOG00049
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00324
Change at Course 1/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Change at Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00328
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Change at Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 2/Week 6
ParticipantsOG00052
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00329
Change at Course 2/Week 13
ParticipantsOG00052
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Baseline B3281001
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG0005.54± 0.896
OG0015.81± 0.956
OG0025.79± 1.019
OG003
Change at Course 1/Week 1
ParticipantsOG00044
ParticipantsOG00126
ParticipantsOG00228
ParticipantsOG00323
Change at Course 1/Week 6
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Change at Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Change at Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Change at Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 6
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00327
Change at Course 2/Week 13
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00325
Change at Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Change at Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00325
Change at Course 3/Week 25
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00327
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00051
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00325
ParticipantsOG00428
Title
Measurements
OG00013.7
OG00125.0
OG00232.3
OG003
Course 1/Week 6
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00130
ParticipantsOG00233
ParticipantsOG00329
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00049
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00324
ParticipantsOG00427
Title
Measurements
OG00014.3
OG00126.9
OG00231.0
OG003
Course 1/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00328
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 6
ParticipantsOG00052
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00052
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00044
ParticipantsOG00126
ParticipantsOG00228
ParticipantsOG00323
ParticipantsOG00427
Title
Measurements
OG00015.9
OG00126.9
OG00228.6
OG003
Course 1/Week 6
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 6
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00327
Course 2/Week 13
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00325
Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00325
Course 3/Week 25 (EOT)
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00327
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00051
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00325
ParticipantsOG00428
Title
Measurements
OG00013.7
OG00125.0
OG00232.3
OG003
Course 1/Week 6
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00130
ParticipantsOG00233
ParticipantsOG00329
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00049
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00324
ParticipantsOG00427
Title
Measurements
OG00014.3
OG00126.9
OG00231.0
OG003
Course 1/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00328
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 6
ParticipantsOG00052
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00052
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00044
ParticipantsOG00126
ParticipantsOG00228
ParticipantsOG00323
ParticipantsOG00427
Title
Measurements
OG00015.9
OG00126.9
OG00228.6
OG003
Course 1/Week 6
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 6
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00327
Course 2/Week 13
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00325
Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00325
Course 3/Week 25 (EOT)
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00327
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00051
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00325
ParticipantsOG00428
Title
Measurements
OG0003.9
OG00110.7
OG00219.4
OG003
Course 1/Week 6
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00232
ParticipantsOG00330
Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00130
ParticipantsOG00233
ParticipantsOG00329
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00049
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00324
ParticipantsOG00427
Title
Measurements
OG0004.1
OG00111.5
OG00217.2
OG003
Course 1/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00328
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 6
ParticipantsOG00052
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00052
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00044
ParticipantsOG00126
ParticipantsOG00228
ParticipantsOG00323
ParticipantsOG00427
Title
Measurements
OG0004.5
OG00111.5
OG00214.3
OG003
Course 1/Week 6
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 6
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00327
Course 2/Week 13
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00325
Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00325
Course 3/Week 25 (EOT)
ParticipantsOG00047
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00327
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG00050.0
OG00159.4
OG00263.6
OG003
Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG00051.9
OG00160.0
OG00264.5
OG003
Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00328
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG00050.0
OG00160.0
OG00263.3
OG003
Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Course 3/Week 25 (EOT)
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG00017.2
OG00128.1
OG00248.5
OG003
Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG00018.5
OG00126.7
OG00248.4
OG003
Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00328
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG00018.8
OG00126.7
OG00246.7
OG003
Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Course 3/Week 25 (EOT)
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG0005.2
OG00112.5
OG00221.2
OG003
Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG0005.6
OG00110.0
OG00219.4
OG003
Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00328
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG0006.3
OG00110.0
OG00216.7
OG003
Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Course 3/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Course 3/Week 25 (EOT)
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Change at Screening
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG000-52.2± 31.46
OG001-57.1± 37.14
OG002-64.2± 29.79
OG003
Change at Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Change at Screening
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG000-54.1± 31.00
OG001-56.0± 38.11
OG002-64.7± 28.61
OG003
Change at Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Change at Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Change at Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00328
Change at Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Change at Screening
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG000-53.4± 31.93
OG001-56.0± 38.11
OG002-63.5± 28.31
OG003
Change at Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Change at Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Change at Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Change at Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Change at Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Change at Course 3/Week 25
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Change at Screening
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG000-58.1± 33.22
OG001-54.2± 39.43
OG002-62.9± 32.45
OG003
Change at Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Change at Screening
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG000-60.4± 29.31
OG001-52.5± 40.15
OG002-64.0± 30.26
OG003
Change at Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Change at Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Change at Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00328
Change at Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Change at Screening
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG000-60.5± 30.41
OG001-52.5± 40.15
OG002-62.7± 30.01
OG003
Change at Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Change at Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Change at Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Change at Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Change at Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Change at Course 3/Week 25
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG000-18.2± 67.42
OG001-36.3± 44.85
OG002-44.0± 58.90
OG003
Change at Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG000-19.4± 68.24
OG001-34.9± 44.82
OG002-43.2± 59.94
OG003
Change at Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Change at Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Change at Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Change at Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG000-19.1± 70.91
OG001-34.9± 44.82
OG002-41.6± 60.23
OG003
Change at Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Change at Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Change at Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Change at Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Change at Course 3/Week 25
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00057
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00429
Title
Measurements
OG000-18.9± 62.81
OG001-43.8± 41.27
OG002-40.3± 55.42
OG003
Change at Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 13
ParticipantsOG00055
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00428
Title
Measurements
OG000-21.5± 62.57
OG001-41.7± 41.50
OG002-40.5± 55.52
OG003
Change at Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Change at Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Change at Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Change at Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
ParticipantsOG00428
Title
Measurements
OG000-21.7± 65.60
OG001-41.7± 41.50
OG002-38.8± 55.71
OG003
Change at Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Change at Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Change at Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Change at Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Change at Course 3/Week 25
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG000-40.3± 42.01
OG001-46.1± 42.81
OG002-54.2± 34.06
OG003
Change at Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG000-41.3± 42.20
OG001-45.4± 43.77
OG002-54.4± 33.27
OG003
Change at Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Change at Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00328
Change at Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Change at Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Change at Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG000-39.7± 43.82
OG001-45.4± 43.77
OG002-53.1± 32.94
OG003
Change at Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Change at Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00326
Change at Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Change at Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Change at Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Change at Course 3/Week 25
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00228
ParticipantsOG00327
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG000-12.2± 54.91
OG001-31.0± 38.52
OG002-39.1± 45.85
OG003
Change at Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG000-15.6± 45.37
OG001-29.3± 37.54
OG002-40.0± 43.05
OG003
Change at Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Change at Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Change at Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Change at Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Change at Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00048
OG00130
OG00230
OG00327
OG00429
Title
Denominators
Categories
Change at Course 1/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
ParticipantsOG00429
Title
Measurements
OG000-13.9± 46.19
OG001-29.3± 37.54
OG002-38.6± 42.99
OG003
Change at Course 1/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 1/Week 25
ParticipantsOG00032
ParticipantsOG00110
ParticipantsOG00219
ParticipantsOG00311
Change at Course 2/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 6
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00327
Change at Course 2/Week 13
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 2/Week 25
ParticipantsOG00026
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00314
Change at Course 3/Week 1
ParticipantsOG00048
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
Change at Course 3/Week 13
ParticipantsOG00046
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00326
Change at Course 3/Week 25
ParticipantsOG00047
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00327
OG001
Rituximab-EU: by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 1
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US: by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 1
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00058
OG00132
OG00233
OG00330
OG00430
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00058
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG00330
ParticipantsOG00430
Title
Measurements
OG0001.4± 0.66
OG0011.1± 0.73
OG0021.0± 0.63
OG003
Course 1/Week 6
ParticipantsOG00057
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 13
ParticipantsOG00056
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00330
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00222
ParticipantsOG00313
OG001
Rituximab-EU/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 2
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586: by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 2
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
Units
Counts
Participants
OG00054
OG00130
OG00231
OG00329
OG00429
Title
Denominators
Categories
Course 1/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
ParticipantsOG00429
Title
Measurements
OG0001.4± 0.68
OG0011.2± 0.72
OG0021.0± 0.60
OG003
Course 1/Week 6
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 1/Week 13
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 1/Week 25
ParticipantsOG00035
ParticipantsOG00110
ParticipantsOG00220
ParticipantsOG00312
Course 2/Week 1
ParticipantsOG00054
ParticipantsOG00130
ParticipantsOG00231
ParticipantsOG00329
Course 2/Week 6
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Course 2/Week 13
ParticipantsOG00053
ParticipantsOG00130
ParticipantsOG00230
ParticipantsOG00329
Course 2/Week 25
ParticipantsOG00029
ParticipantsOG0019
ParticipantsOG00220
ParticipantsOG00315
OG001
Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG002
PF-05280586 (EU): by the End of Course 3
This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
OG003
Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
OG004
PF-05280586 (US): by the End of Course 3
This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.