A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab... | NCT02222493 | Trialant
NCT02222493
Sponsor
Pfizer
Status
Completed
Last Update Posted
May 30, 2018Actual
Enrollment
650Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
PF-06438179
Infliximab
Countries
United States
Australia
Bosnia and Herzegovina
Brazil
Bulgaria
Canada
Czechia
Georgia
Germany
Guatemala
Hungary
Israel
Japan
Jordan
Lithuania
Mexico
Morocco
Peru
Philippines
Poland
Romania
Russia
Serbia
South Africa
South Korea
Tunisia
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02222493
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B5371002
Secondary IDs
ID
Type
Description
Link
REFLECTIONS B537-02
Other Identifier
Alias ID
2013-004148-49
EudraCT Number
Brief Title
A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Official Title
A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2018
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 26, 2014Actual
Primary Completion Date
Jun 29, 2016Actual
Completion Date
Jun 1, 2017Actual
First Submitted Date
Aug 19, 2014
First Submission Date that Met QC Criteria
Aug 19, 2014
First Posted Date
Aug 21, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 26, 2017
Results First Submitted that Met QC Criteria
Aug 9, 2017
Results First Posted Date
Sep 11, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 26, 2017
Certification/Extension First Submitted that Passed QC Review
Jun 26, 2017
Certification/Extension First Posted Date
Jun 27, 2017Actual
Last Update Submitted Date
Apr 30, 2018
Last Update Posted Date
May 30, 2018Actual
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
The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Phase 3
infliximab
rheumatoid arthritis
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
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
650Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-06438179
Experimental
Biological: PF-06438179
Infliximab
Active Comparator
Biological: Infliximab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06438179
Biological
PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
PF-06438179
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP).
Week 14
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
HS-CRP equal or greater than 10 mg/L.
Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.
Exclusion Criteria:
Evidence of untreated or inadequately treated latent or active TB.
Evidence or history of moderate or severe heart failure (NYHA Class III/IV)
Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Achieve Clinical Research, LLC
Birmingham
Alabama
35216
United States
Clinical and Translational Research Center of Alabama, PC
Kay J, Bock AE, Rehman M, Zhang W, Zhang M, Iikuni N, Alvarez DF. Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis. RMD Open. 2022 Sep;8(2):e002423. doi: 10.1136/rmdopen-2022-002423.
Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, Zhang M, Hackley S, Rehman MI, von Richter O, Alten R. Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial. BioDrugs. 2020 Apr;34(2):197-207. doi: 10.1007/s40259-019-00403-z.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
A total of 1603 participants were screened after signing an informed consent form, of whom 650 participants were randomized to receive study treatment. One (1) participant in the PF-06438179 arm was screened and randomized by 2 different study site personnel, and no data were collected for the participant's second randomization.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PF-06438179
Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Infliximab
Infliximab-EU, Remicade
Week 2, 4, 6, 12, 22 and 30 (pre-dose)
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
Week 38, 46 and 54 (pre-dose)
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
Week 62, 70 and 78
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1
ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2
ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
Week 38, 46 and 54 (pre-dose)
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3
ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
Week 62, 70 and 78
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale [VAS] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (<)2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and greater than (>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2
DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Baseline (Week 30 pre-dose), Week 38, 46 and 54
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3
DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1
ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2
ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
Week 38, 46 and 54 (pre-dose)
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3
ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
Week 62, 70 and 78
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1
EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2
EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
Week 38, 46 and Week 54 (pre-dose)
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3
EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
Week 62, 70 and Week 78
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Baseline (Day 1) up to Week 30
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Baseline (Week 30 pre-dose) up to Week 54
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Baseline (Week 54 pre-dose) up to Week 78
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1
AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Baseline (Day 1) up to Week 30
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2
AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Baseline (Week 30 pre-dose) up to Week 54
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3
AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Baseline (Week 54 pre-dose) up to Week 78
Number of Participants With Laboratory Abnormalities: Period 1
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.
Baseline (Day 1) up to Week 30
Number of Participants With Laboratory Abnormalities: Period 2
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.
Baseline (Week 30 pre-dose) up to Week 54
Number of Participants With Laboratory Abnormalities: Period 3
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.
Baseline (Week 54 pre-dose) up to Week 78
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2
Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Baseline (Week 30 pre-dose), Week 38, 46 and Week 54
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3
Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1
PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2
PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Baseline (Week 30 pre-dose), Week 38, 46 and 54
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3
PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2
Baseline (Week 30 pre-dose), Week 38, 46 and 54
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3
Baseline (Week 54 pre-dose), Week 62, 70 and 78
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1
ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Baseline (Day 1) up to Week 30
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2
ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Baseline (Week 30 pre-dose) up to Week 54
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3
ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Baseline (Week 54 pre-dose) up to Week 78
Serum Concentration Versus Time Summary: Period 1
Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29
Serum Concentration Versus Time Summary: Period 2
Pre dose on Day 211, 267, 379 and 547
Serum Concentration Versus Time Summary: Period 3
Pre dose on Day 379, 435 and 547
Tuscaloosa
Alabama
35406
United States
Sun Valley Arthritis Center, Ltd.
Peoria
Arizona
85381
United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix
Arizona
85037
United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton
California
92835
United States
Arthritis & Osteoporosis Medical Center
La Palma
California
90623
United States
Inland Rheumatology Clinical Trials, Inc.
Upland
California
91786
United States
Desert Valley Medical Group
Victorville
California
92395
United States
Javed Rheumatology Associates, Inc
Newark
Delaware
19713
United States
Arthritis and Rheumatic Disease Specialties
Aventura
Florida
33180
United States
International Medical Research
Daytona Beach
Florida
32117
United States
Daytona Beach
Florida
32117
United States
San Marcus Research Clinic, Inc.
Miami
Florida
33015
United States
Advance Medical Research Services Corporation
Miami
Florida
33165
United States
Sarasota Arthritis Research Center
Sarasota
Florida
34239
United States
Alastair C. Kennedy, MD
Vero Beach
Florida
32960
United States
Indian River Primary Care
Vero Beach
Florida
32960
United States
Harbin Clinic
Rome
Georgia
30165
United States
Advanced Clinical Research
Meridian
Idaho
83642
United States
Methodist Medical Center of IL
Peoria
Illinois
61636
United States
Physician's Clinic of Iowa, P.C.
Cedar Rapids
Iowa
52403
United States
Gilbert-Graves Clinic
Bowling Green
Kentucky
42101
United States
Graves-Gilbert Clinic Bowling Green
Bowling Green
Kentucky
42101
United States
Ochsner Clinic Baton Rouge
Baton Rouge
Louisiana
70809
United States
Arthritis and Diabetes Clinic, Inc.
Monroe
Louisiana
71203
United States
The Center for Rheumatology and Bone Research
Wheaton
Maryland
20902
United States
Western Michigan University Homer Stryker MD School of Medicine Center for Clinical Research
Battle Creek
Michigan
49015
United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township
New Jersey
08043
United States
Trinity Health Center-Medical Arts
Minot
North Dakota
58701
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
Clinical Research Center of Reading, LLC
Wyomissing
Pennsylvania
19610
United States
Low Country Rheumatology, PA
Charleston
South Carolina
29406
United States
Regional Health Clinical Research
Rapid City
South Dakota
57701
United States
Regional Medical Clinic
Rapid City
South Dakota
57701
United States
West Tennessee Research Institute
Jackson
Tennessee
38305
United States
Ramesh C Gupta, MD
Memphis
Tennessee
38119
United States
Austin Regional Clinic
Austin
Texas
78731
United States
Metroplex Clinical Research Center
Dallas
Texas
75231
United States
Accurate Clinical Research, Inc.
Houston
Texas
77034
United States
Accurate Clinical Research
Nassau Bay
Texas
77058
United States
Pharmacy Services, Sentara Leigh Hospital
Norfolk
Virginia
23502
United States
Sentara Medical Group, Clinical Research
Norfolk
Virginia
23502
United States
The Seattle Arthritis Clinic
Seattle
Washington
98133
United States
Gold Coast Private Hospital Pty Ltd
Southport
Queensland
4215
Australia
HPS Pharmacies
Southport
Queensland
4215
Australia
Paradise Arthritis and Rheumatology Pty Ltd
Southport
Queensland
4215
Australia
The Queen Elizabeth Hospital
Woodville South
South Australia
5011
Australia
CliniPath Pathology
Osborne Park
Western Australia
6017
Australia
R.K. Will Pty Ltd
Victoria Park
Western Australia
6100
Australia
Clinical Center University of Sarajevo
Sarajevo
Kanton Sarajevo
71000
Bosnia and Herzegovina
General Hospital "Prim.dr.Abdulah Nakas"
Sarajevo
Kanton Sarajevo
71000
Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla
Tuzlanski Kanton
75000
Bosnia and Herzegovina
University Hospital Clinical Center Banja Luka
Banja Luka
78000
Bosnia and Herzegovina
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba
Paraná
80030-110
Brazil
Hospital Israelita Albert Einstein
São Paulo
05652-900
Brazil
Multiprofile Hospital for Active Treatment Trimontium OOD
Plovdiv
4000
Bulgaria
University Multiprofile Hospital for Active Treatment (UMHAT) "Kaspela" EOOD
Plovdiv
4002
Bulgaria
University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Ivan Rilski" EAD
Sofia
1612
Bulgaria
Clinical Research and Arthritis Center
Windsor
Ontario
N8X 2C9
Canada
CCBR Czech Brno, s.r.o.
Brno
602 00
Czechia
Lekarna Lancier, s.r.o.
Brno
602 00
Czechia
BENU Lekarna
Pardubice
530 02
Czechia
CCBR-SYNARC a.s.
Pardubice
530 02
Czechia
CCBR Czech Prague, s.r.o.
Prague
130 00
Czechia
Lekarna U Robina, s.r.o.
Prague
130 00
Czechia
Lekarna Hradebni s.r.o.
Uherské Hradiště
686 01
Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště
686 01
Czechia
LTD Tbilisi Central Hospital
Tbilisi
0159
Georgia
LTD Unimedi Kakheti
Tbilisi
0159
Georgia
Tbilisi Heart and Vascular Clinic LTD
Tbilisi
0159
Georgia
LTD MediClubGeorgia
Tbilisi
0160
Georgia
LTD Adapti
Tbilisi
0186
Georgia
LTD Medulla" Chemotherapy and Immunotherapy Clinic
Tbilisi
0186
Georgia
Schlosspark-Klinik
Berlin
14059
Germany
Klinikum der Universität München
München
80336
Germany
Elisabeth-Klinik gGmbH
Olsberg
59939
Germany
Knappschaftsklinikum Saar GmbH
Püttlingen
66346
Germany
Rheumazentrum Ratingen
Ratingen
40878
Germany
Clínica Médica Especializada en Medicina Interna y Reumatología
Guatemala City
01010
Guatemala
Clínica Médica especializada en Medicina Interna
Guatemala City
01011
Guatemala
Centro de Nutricion y Rehabilitacion Cardiorespiratoria, S.A. (NUCARE)
Guatemala City
01015
Guatemala
Therapeutic Research Institute and Lab S.A
Guatemala City
01015
Guatemala
DRC Gyógyszervizsgáló Központ Kft.
Balatonfüred
8230
Hungary
Qualiclinic Kft.
Budapest
1036
Hungary
Rambam Health Care Campus
Haifa
3109601
Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
Jerusalem
91120
Israel
Meir Medical Center
Kfar Saba
4428164
Israel
Anjo Kosei Hospital
Anjo-shi
Aichi-ken
446-8602
Japan
Aso Iizuka Hospital
Iiduka
Fukuoka
820-8505
Japan
Inoue Hospital
Takasaki
Gunma
370-0053
Japan
Mazda Hospital
Aki-gun
Hiroshima
735-8585
Japan
Sapporo City General Hospital
Sapporo
Hokkaido
060-8604
Japan
Hokkaido University Hospital
Sapporo
Hokkaido
060-8648
Japan
Matsubara Mayflower Hospital
Katoh
Hyōgo
673-1462
Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara
Kanagawa
252-0392
Japan
Yokohama Minami Kyosai Hospital
Yokohama
Kanagawa
236-0037
Japan
National Hospital Organization Nagasaki Medical Center
Ōmura
Nagasaki
856-8562
Japan
Sasebo Chuo Hospital
Sasebo
Nagasaki
857-1195
Japan
Kurashiki Sweet Hospital
Kurashiki
Okayama-ken
710-0016
Japan
Yuaikai Tomishiro Central Hospital
Tomigusuku
Okinawa
901-0243
Japan
Saitama Medical Center
Kawagoe-shi
Saitama
350-8550
Japan
Hirose Clinic
Tokorozawa-shi
Saitama
359-1111
Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun
Shizuoka
411-8611
Japan
St. Luke's International Hospital
Chuo-ku
Tokyo
104-8560
Japan
Toho University Ohashi Medical Center
Meguro-ku
Tokyo
153-8515
Japan
Showa University Hospital
Shinagawa-ku
Tokyo
142-8666
Japan
National Hospital Organization Chiba-East Hospital
Chiba
260-8712
Japan
Kondo clinic for rheumatism and orthopaedics
Fukuoka
810-0001
Japan
National Hospital Organization Kyushu Medical Center
Fukuoka
810-8563
Japan
Kumamoto Orthopaedic Hospital
Kumamoto
862-0976
Japan
Jordan Hospital
Amman
11152
Jordan
King Abdullah University Hospital
Irbid
22110
Jordan
LSMUL Kauno klinikos
Kaunas
LT-50009
Lithuania
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
San Luis de Potosí
SAN LUIS de Potosi
78213
Mexico
Unidad de Investigaciones Reumatológicas A.C - Hospital Central "Dr. Ignacio Morones Prieto"
Zona Universitaria
SAN LUIS de Potosi
CP 78240
Mexico
Unidad Reumatologica Las Americas S.C.P
Mérida
Yucatán
CP 97000
Mexico
El Ayachi Hospital
Salé
11150
Morocco
Groupe Radiologique de Salé
Salé
11150
Morocco
Laboratoire les Arcades d'Analyses Médicales
Salé
11150
Morocco
Hospital María Auxiliadora - Centro de Investigaciones Medicas
San Juan de Miraflores
Lima region
Lima 29
Peru
Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva
Santiago de Surco
Lima region
Lima 33
Peru
Centro de diagnóstico por imágenes, Radiología General y Especial
Arequipa
CP656
Peru
Unidad de Investigación en Medicina Interna y Enfermedades Críticas
Arequipa
CP656
Peru
Centro de Investigación Reumatología CAA
Lima
Lima 27
Peru
Clinica Medica Cayetano Heredia
Lima
Lima 31
Peru
Servicio de Inmunología y Reumatología
Lima
Lima 31
Peru
Mary Mediatrix Medical Center
Lipa City
Batangas
4217/043
Philippines
Southern Philippines Medical Center
Davao City
Davao DEL SUR
8000
Philippines
Makati Medical Center
Makati City
National Capital Region
1229
Philippines
Medical Center Manila
Manila
1000
Philippines
Philippine General Hospital
Manila
1000
Philippines
St. Luke's Medical Center
Quezon
1102
Philippines
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz
85-168
Poland
Szpital Specjalistyczny im. J. Dietla Malopolskie Centrum Reumatologii Immunologii i Rehabilitacji
Krakow
31-121
Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn
05-830
Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól
67-100
Poland
MTZ Clinical Research Sp. z o.o.
Warsaw
02-106
Poland
Spitalul Clinic Judetean de Urgenta Galati "Sf. Apostol Andrei"
Galati
800578
Romania
Spitalul Clinic de Recuperare Iasi
Iași
700656
Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş
540136
Romania
GBUZ "Republican hospital n.a. V.A.Baranov"
Petrozavodsk
Republic of Karelia
185019
Russia
GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"
Palaparthy R, Rehman MI, von Richter O, Yin D. Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis. Expert Opin Biol Ther. 2019 Oct;19(10):1065-1074. doi: 10.1080/14712598.2019.1635583. Epub 2019 Jul 8.
Alten R, Batko B, Hala T, Kameda H, Radominski SC, Tseluyko V, Babic G, Cronenberger C, Hackley S, Rehman M, von Richter O, Zhang M, Cohen S. Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54. RMD Open. 2019 Mar 28;5(1):e000876. doi: 10.1136/rmdopen-2018-000876. eCollection 2019.
Cohen SB, Alten R, Kameda H, Hala T, Radominski SC, Rehman MI, Palaparthy R, Schumacher K, Schmitt S, Hua SY, Ianos C, Sewell KL. A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. Arthritis Res Ther. 2018 Jul 27;20(1):155. doi: 10.1186/s13075-018-1646-4.
FG001
Infliximab-EU Remicade (INX)
Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
FG000324 subjects
FG001326 subjects
Received Treatment
FG000323 subjects
FG001326 subjects
COMPLETED
FG000280 subjects
FG001286 subjects
NOT COMPLETED
FG00044 subjects
FG00140 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0012 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
Withdrawal by Subject
FG00011 subjects
FG0019 subjects
Protocol Violation
FG0005 subjects
FG0011 subjects
Insufficient clinical response
FG0000 subjects
FG0017 subjects
Non-compliance with study treatment
FG0001 subjects
FG0010 subjects
Pregnancy
FG0002 subjects
FG0010 subjects
Adverse Event
FG00018 subjects
FG00120 subjects
Other
FG0004 subjects
FG0010 subjects
Randomized but not treated
FG0001 subjects
FG0010 subjects
Period 2: Week30 Dosing-Week54(Pre-dose)
Type
Comment
Milestone Data
STARTED
FG000423 subjects
FG001143 subjects
COMPLETED
FG000380 subjects
FG001126 subjects
NOT COMPLETED
FG00043 subjects
FG00117 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
Adverse Event
FG00022 subjects
FG001
Period 3: Week 54 Dosing-Week 78 Visit
Type
Comment
Milestone Data
STARTED
FG000505 subjects
FG0010 subjects
COMPLETED
FG000474 subjects
FG0010 subjects
NOT COMPLETED
FG00031 subjects
FG0010 subjects
Type
Comment
Reasons
Insufficient clinical response
FG0003 subjects
FG0010 subjects
Adverse Event
FG00014 subjects
FG001
The Intent-to-Treat (ITT) Population was defined as all participants who were randomized to study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PF-06438179
Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
BG001
Infliximab-EU Remicade (INX)
Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000324
BG001326
BG002650
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
BG00052.8± 13.3
BG00152.8± 12.9
BG00252.8± 13.1
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000258
BG001264
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
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP).
The ITT Population was defined as all participants who were randomized to study treatment. The primary analyses for ACR20 at Week 14 were performed with the missing data imputed using a non-responder imputation method.
Posted
Number
participants
Week 14
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Units
Counts
Participants
OG000324
OG001326
Title
Denominators
Categories
Title
Measurements
OG000198
OG001207
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Score statistic method
Proportion Difference
-2.39
2-Sided
95
-9.92
5.11
Non-Inferiority or Equivalence
Equivalence test
OG000
OG001
Score statistic method
Secondary
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Number
participants
Week 2, 4, 6, 12, 22 and 30 (pre-dose)
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Number
participants
Week 38, 46 and 54 (pre-dose)
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Secondary
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.
The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.
Posted
Number
participants
Week 62, 70 and 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Secondary
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1
ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Number
participants
Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Secondary
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2
ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Number
participants
Week 38, 46 and 54 (pre-dose)
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Secondary
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3
ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.
The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.
Posted
Number
participants
Week 62, 70 and 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Secondary
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale [VAS] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (<)2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and greater than (>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2
DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 30 pre-dose), Week 38, 46 and 54
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Secondary
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3
DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.
The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 54 pre-dose), Week 62, 70 and 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Secondary
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1
ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Number
participants
Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2
ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Number
participants
Week 38, 46 and 54 (pre-dose)
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Secondary
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3
ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.
The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.
Posted
Number
participants
Week 62, 70 and 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Secondary
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1
EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Number
participants
Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2
EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
The ITT Population was defined as all participants who were randomized to study treatment.
Posted
Number
participants
Week 38, 46 and Week 54 (pre-dose)
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Secondary
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3
EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.
The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.
Posted
Number
participants
Week 62, 70 and Week 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Day 1) up to Week 30
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Week 30 pre-dose) up to Week 54
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Week 54 pre-dose) up to Week 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1
AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Day 1) up to Week 30
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2
AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Week 30 pre-dose) up to Week 54
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3
AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Week 54 pre-dose) up to Week 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Secondary
Number of Participants With Laboratory Abnormalities: Period 1
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.
Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Number
participants
Baseline (Day 1) up to Week 30
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Number of Participants With Laboratory Abnormalities: Period 2
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.
Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Number
participants
Baseline (Week 30 pre-dose) up to Week 54
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Secondary
Number of Participants With Laboratory Abnormalities: Period 3
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.
Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Number
participants
Baseline (Week 54 pre-dose) up to Week 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Secondary
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2
Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
joints
Baseline (Week 30 pre-dose), Week 38, 46 and Week 54
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Secondary
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3
Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.
The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
joints
Baseline (Week 54 pre-dose), Week 62, 70 and 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Secondary
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1
PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2
PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 30 pre-dose), Week 38, 46 and 54
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Secondary
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3
PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.
The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline (Week 54 pre-dose), Week 62, 70 and 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Secondary
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
milligram/litres
Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2
The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
milligrams/litres
Baseline (Week 30 pre-dose), Week 38, 46 and 54
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Secondary
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3
The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
milligrams/litres
Baseline (Week 54 pre-dose), Week 62, 70 and 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Secondary
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1
ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Day 1) up to Week 30
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2
ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Week 30 pre-dose) up to Week 54
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Secondary
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3
ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.
Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.
Posted
Number
participants
Baseline (Week 54 pre-dose) up to Week 78
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Secondary
Serum Concentration Versus Time Summary: Period 1
Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.
Posted
Median
Standard Deviation
nanograms/milliliters
Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29
ID
Title
Description
OG000
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Secondary
Serum Concentration Versus Time Summary: Period 2
Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.
Posted
Mean
Standard Deviation
nanograms/milliliters
Pre dose on Day 211, 267, 379 and 547
ID
Title
Description
OG000
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Secondary
Serum Concentration Versus Time Summary: Period 3
Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.
Posted
Mean
Standard Deviation
nanograms/milliliters
Pre dose on Day 379, 435 and 547
ID
Title
Description
OG000
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Time Frame
Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78
Description
Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.
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
Period 1: PF-06438179
Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
16
323
38
323
EG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
20
326
35
326
EG002
Period 2: PF-06438179/PF-06438179
Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
13
280
8
280
EG003
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
11
143
11
143
EG004
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
4
143
6
143
EG005
Period 3: PF-06438179/PF-06438179/PF-06438179
Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
3
253
0
253
EG006
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
3
126
0
126
EG007
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
6
126
0
126
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 19.0
Non-systematic Assessment
EG0002 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG0030 affected143 at risk
EG0040 affected143 at risk
EG0050 affected253 at risk
EG0060 affected126 at risk
EG0070 affected126 at risk
Angina unstable
Cardiac disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0012 affected326 at risk
EG0020 affected280 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Keratitis
Eye disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Chest pain
General disorders
MedDRA 19.0
Non-systematic Assessment
EG0002 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Multi-organ disorder
General disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Localised infection
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0002 affected323 at risk
EG0012 affected326 at risk
EG0020 affected280 at risk
EG003
Purulent synovitis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Cartilage injury
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0021 affected280 at risk
EG003
Sternal fracture
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0001 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0021 affected280 at risk
EG003
Shock
Vascular disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Venous stenosis
Vascular disorders
MedDRA 19.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0011 affected326 at risk
EG0020 affected280 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Blood disorder
Blood and lymphatic system disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Pyrexia
General disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Laryngeal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Ocular lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Genital prolapse
Reproductive system and breast disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0021 affected280 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Bone abscess
Infections and infestations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Menometrorrhagia
Reproductive system and breast disorders
MedDRA 19.0; 20.0
Non-systematic Assessment
EG0000 affected323 at risk
EG0010 affected326 at risk
EG0020 affected280 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 19.0
Non-systematic Assessment
EG00019 affected323 at risk
EG00121 affected326 at risk
EG0028 affected280 at risk
EG00311 affected143 at risk
EG004
Alanine aminotransferase increased
Investigations
MedDRA 19.0
Non-systematic Assessment
EG00019 affected323 at risk
EG00115 affected326 at risk
EG0020 affected280 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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
ID
Term
C000630865
GP1111
D000069285
Infliximab
Ancestor Terms
ID
Term
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
9 subjects
Other
FG0003 subjects
FG0010 subjects
Non-compliance with study treatment
FG0001 subjects
FG0010 subjects
Withdrawal by Subject
FG0006 subjects
FG0014 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
Insufficient clinical response
FG0009 subjects
FG0013 subjects
0 subjects
Other
FG0004 subjects
FG0010 subjects
Non-compliance with study treatment
FG0001 subjects
FG0010 subjects
Withdrawal by Subject
FG0009 subjects
FG0010 subjects
522
Male
BG00066
BG00162
BG002128
Proportion Difference
-2.39
2-Sided
90
-8.75
4.02
Non-Inferiority or Equivalence
Equivalence test
Units
Counts
Participants
OG000324
OG001326
Title
Denominators
Categories
Week 2
Title
Measurements
OG000105
OG001121
Week 4
Title
Measurements
OG000170
OG001190
Week 6
Title
Measurements
OG000187
OG001201
Week 12
Title
Measurements
OG000210
OG001214
week 22
Title
Measurements
OG000205
OG001213
Week 30 (pre-dose)
Title
Measurements
OG000197
OG001209
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000280
OG001143
OG002143
Title
Denominators
Categories
Week 38
Title
Measurements
OG000206
OG001101
OG002110
Week 46
Title
Measurements
OG000199
OG00198
OG00299
Week 54 (pre-dose)
Title
Measurements
OG000199
OG00192
OG002101
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Units
Counts
Participants
OG000253
OG001126
OG002126
Title
Denominators
Categories
Week 62
Title
Measurements
OG000199
OG00189
OG002103
Week 70
Title
Measurements
OG000199
OG00187
OG00298
Week 78
Title
Measurements
OG000192
OG00186
OG00298
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Units
Counts
Participants
OG000324
OG001326
Title
Denominators
Categories
ACR50 (Week 2)
Title
Measurements
OG00024
OG00124
ACR50 (Week 4)
Title
Measurements
OG00072
OG00159
ACR50 (Week 6)
Title
Measurements
OG00088
OG00180
ACR50 (Week 12)
Title
Measurements
OG00095
OG001101
ACR50 (Week 14)
Title
Measurements
OG000116
OG001108
ACR50 (Week 22)
Title
Measurements
OG000126
OG001116
ACR50 (Week 30, pre-dose)
Title
Measurements
OG000125
OG001132
ACR70 (Week 2)
Title
Measurements
OG0006
OG0016
ACR70 (Week 4)
Title
Measurements
OG00022
OG00113
ACR70 (Week 6)
Title
Measurements
OG00033
OG00116
ACR70 (Week 12)
Title
Measurements
OG00046
OG00140
ACR70 (Week 14)
Title
Measurements
OG00056
OG00133
ACR70 (Week 22)
Title
Measurements
OG00056
OG00145
ACR70 (Week 30, pre-dose)
Title
Measurements
OG00067
OG00158
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000280
OG001143
OG002143
Title
Denominators
Categories
ACR50 (Week 38)
Title
Measurements
OG000132
OG00158
OG00275
ACR50 (Week 46)
Title
Measurements
OG000135
OG00155
OG00263
ACR50 (Week 54, pre-dose)
Title
Measurements
OG000135
OG00161
OG00265
ACR70 (Week 38)
Title
Measurements
OG00077
OG00133
OG00238
ACR70 (Week 46)
Title
Measurements
OG00075
OG00133
OG00233
ACR70 (Week 54, pre-dose)
Title
Measurements
OG00082
OG00133
OG00235
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Units
Counts
Participants
OG000253
OG001126
OG002126
Title
Denominators
Categories
ACR50 (Week 62)
Title
Measurements
OG000132
OG00159
OG00271
ACR50 (Week 70)
Title
Measurements
OG000142
OG00161
OG00267
ACR50 (Week 78)
Title
Measurements
OG000150
OG00157
OG00273
ACR70 (Week 62)
Title
Measurements
OG00088
OG00131
OG00241
ACR70 (Week 70)
Title
Measurements
OG00092
OG00135
OG00244
ACR70 (Week 78)
Title
Measurements
OG00098
OG00133
OG00244
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Units
Counts
Participants
OG000324
OG001326
Title
Denominators
Categories
DAS28-CRP (Baseline)
ParticipantsOG000321
ParticipantsOG001325
Title
Measurements
OG0005.950± 0.9577
OG0015.983± 0.9210
DAS28-CRP (Change at Week 2)
ParticipantsOG000318
ParticipantsOG001324
Title
Measurements
OG000-1.213± 0.9280
OG001
DAS28-CRP (Change at Week 4)
ParticipantsOG000312
ParticipantsOG001315
Title
Measurements
OG000-1.596± 1.1259
OG001
DAS28-CRP (Change at Week 6)
ParticipantsOG000312
ParticipantsOG001319
Title
Measurements
OG000-1.710± 1.1959
OG001
DAS28-CRP (Change at Week 12)
ParticipantsOG000310
ParticipantsOG001316
Title
Measurements
OG000-1.898± 1.3516
OG001
DAS28-CRP (Change at Week 14)
ParticipantsOG000310
ParticipantsOG001314
Title
Measurements
OG000-1.901± 1.4125
OG001
DAS28-CRP (Change at Week 22)
ParticipantsOG000301
ParticipantsOG001307
Title
Measurements
OG000-2.005± 1.4236
OG001
DAS28-CRP (Change at Week 30)
ParticipantsOG000292
ParticipantsOG001297
Title
Measurements
OG000-2.140± 1.4197
OG001
HAQ-DI (Baseline)
ParticipantsOG000321
ParticipantsOG001325
Title
Measurements
OG0001.623± 0.6485
OG001
HAQ-DI (Change at Week 2)
ParticipantsOG000320
ParticipantsOG001324
Title
Measurements
OG000-0.317± 0.4100
OG001
HAQ-DI (Change at Week 4)
ParticipantsOG000317
ParticipantsOG001321
Title
Measurements
OG000-0.472± 0.4728
OG001
HAQ-DI (Change at Week 6)
ParticipantsOG000314
ParticipantsOG001320
Title
Measurements
OG000-0.496± 0.5505
OG001
HAQ-DI (Change at Week 12)
ParticipantsOG000311
ParticipantsOG001318
Title
Measurements
OG000-0.535± 0.5795
OG001
HAQ-DI (Change at Week 14)
ParticipantsOG000311
ParticipantsOG001316
Title
Measurements
OG000-0.572± 0.5910
OG001
HAQ-DI (Change at Week 22)
ParticipantsOG000301
ParticipantsOG001311
Title
Measurements
OG000-0.588± 0.6061
OG001
HAQ-DI (Change at Week 30)
ParticipantsOG000294
ParticipantsOG001298
Title
Measurements
OG000-0.621± 0.6484
OG001
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000278
OG001142
OG002141
Title
Denominators
Categories
DAS28-CRP (Baseline)
ParticipantsOG000278
ParticipantsOG001142
ParticipantsOG002141
Title
Measurements
OG0003.765± 1.4629
OG0013.819± 1.3624
OG0023.781± 1.2547
DAS28-CRP (Change at Week 38)
ParticipantsOG000276
ParticipantsOG001141
ParticipantsOG002140
Title
Measurements
OG000
DAS28-CRP (Change at Week 46)
ParticipantsOG000266
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
DAS28-CRP (Change at Week 54)
ParticipantsOG000256
ParticipantsOG001129
ParticipantsOG002128
Title
Measurements
OG000
HAQ-DI (Change at Baseline)
ParticipantsOG000278
ParticipantsOG001142
ParticipantsOG002141
Title
Measurements
OG000
HAQ-DI (Change at Week 38)
ParticipantsOG000277
ParticipantsOG001141
ParticipantsOG002141
Title
Measurements
OG000
HAQ-DI (Change at Week 46)
ParticipantsOG000269
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
HAQ-DI (Change at Week 54)
ParticipantsOG000259
ParticipantsOG001130
ParticipantsOG002129
Title
Measurements
OG000
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Units
Counts
Participants
OG000249
OG001123
OG002126
Title
Denominators
Categories
DAS28-CRP (Baseline)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002124
Title
Measurements
OG0003.386± 1.3229
OG0013.561± 1.3123
OG0023.594± 1.2572
DAS28-CRP (Change at Week 62)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002124
Title
Measurements
OG000
DAS28-CRP (Change at Week 70)
ParticipantsOG000244
ParticipantsOG001119
ParticipantsOG002121
Title
Measurements
OG000
DAS28-CRP (Change at Week 78)
ParticipantsOG000239
ParticipantsOG001114
ParticipantsOG002118
Title
Measurements
OG000
HAQ-DI (Baseline)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002126
Title
Measurements
OG000
HAQ-DI (Change at Week 62)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002124
Title
Measurements
OG000
HAQ-DI (Change at Week 70)
ParticipantsOG000244
ParticipantsOG001119
ParticipantsOG002122
Title
Measurements
OG000
HAQ-DI (Change at Week 78)
ParticipantsOG000239
ParticipantsOG001116
ParticipantsOG002118
Title
Measurements
OG000
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Units
Counts
Participants
OG000324
OG001326
Title
Denominators
Categories
ACR/EULAR remission (Week 2)
Title
Measurements
OG0002
OG0013
ACR/EULAR remission (Week 4)
Title
Measurements
OG00010
OG00111
ACR/EULAR remission (Week 6)
Title
Measurements
OG00012
OG00110
ACR/EULAR remission (Week 12)
Title
Measurements
OG00028
OG00117
ACR/EULAR remission (Week 14)
Title
Measurements
OG00027
OG00122
ACR/EULAR remission (Week 22)
Title
Measurements
OG00025
OG00120
ACR/EULAR remission (Week 30, pre-dose)
Title
Measurements
OG00030
OG00123
DAS remission (Week 2)
Title
Measurements
OG0009
OG00117
DAS remission (Week 4)
Title
Measurements
OG00028
OG00132
DAS remission (Week 6)
Title
Measurements
OG00040
OG00135
DAS remission (Week 12)
Title
Measurements
OG00052
OG00144
DAS remission (Week 14)
Title
Measurements
OG00053
OG00143
DAS remission (Week 22)
Title
Measurements
OG00058
OG00150
DAS remission (Week 30, pre-dose)
Title
Measurements
OG00062
OG00154
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000280
OG001143
OG002143
Title
Denominators
Categories
ACR/EULAR remission (Week 38)
Title
Measurements
OG00029
OG00115
OG0028
ACR/EULAR remission (Week 46)
Title
Measurements
OG00039
OG00115
OG0027
ACR/EULAR remission (Week 54, pre-dose)
Title
Measurements
OG00042
OG00118
OG00213
DAS remission (Week 38)
Title
Measurements
OG00074
OG00126
OG00225
DAS remission (Week 46)
Title
Measurements
OG00076
OG00130
OG00221
DAS remission (Week 54, pre-dose)
Title
Measurements
OG00079
OG00133
OG00229
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Units
Counts
Participants
OG000253
OG001126
OG002126
Title
Denominators
Categories
ACR/EULAR remission (Week 62)
Title
Measurements
OG00046
OG00119
OG00220
ACR/EULAR remission (Week 70)
Title
Measurements
OG00050
OG00118
OG00219
ACR/EULAR remission (Week 78)
Title
Measurements
OG00057
OG00119
OG00218
DAS remission (Week 62)
Title
Measurements
OG00085
OG00133
OG00234
DAS remission (Week 70)
Title
Measurements
OG00082
OG00140
OG00234
DAS remission (Week 78)
Title
Measurements
OG00094
OG00139
OG00241
Units
Counts
Participants
OG000324
OG001326
Title
Denominators
Categories
Week 2 (good response)
ParticipantsOG000317
ParticipantsOG001324
Title
Measurements
OG00024
OG00134
Week 2 (moderate response)
ParticipantsOG000317
ParticipantsOG001324
Title
Measurements
OG000172
OG001
Week 2 (no response)
ParticipantsOG000317
ParticipantsOG001324
Title
Measurements
OG000121
OG001
Week 4 (good response)
ParticipantsOG000312
ParticipantsOG001315
Title
Measurements
OG00061
OG001
Week 4 (moderate response)
ParticipantsOG000312
ParticipantsOG001315
Title
Measurements
OG000162
OG001
Week 4 (no response)
ParticipantsOG000312
ParticipantsOG001315
Title
Measurements
OG00089
OG001
Week 6 (good response)
ParticipantsOG000312
ParticipantsOG001319
Title
Measurements
OG00065
OG001
Week 6 (moderate response)
ParticipantsOG000312
ParticipantsOG001319
Title
Measurements
OG000168
OG001
Week 6 (no response)
ParticipantsOG000312
ParticipantsOG001319
Title
Measurements
OG00079
OG001
Week 12 (good response)
ParticipantsOG000310
ParticipantsOG001316
Title
Measurements
OG00090
OG001
Week 12 (moderate response)
ParticipantsOG000310
ParticipantsOG001316
Title
Measurements
OG000149
OG001
Week 12 (no response)
ParticipantsOG000310
ParticipantsOG001316
Title
Measurements
OG00071
OG001
Week 14 (good response)
ParticipantsOG000310
ParticipantsOG001314
Title
Measurements
OG00097
OG001
Week 14 (moderate response)
ParticipantsOG000310
ParticipantsOG001314
Title
Measurements
OG000137
OG001
Week 14 (no response)
ParticipantsOG000310
ParticipantsOG001314
Title
Measurements
OG00076
OG001
Week 22 (good response)
ParticipantsOG000301
ParticipantsOG001307
Title
Measurements
OG000103
OG001
Week 22 (moderate response)
ParticipantsOG000301
ParticipantsOG001307
Title
Measurements
OG000125
OG001
Week 22 (no response)
ParticipantsOG000301
ParticipantsOG001307
Title
Measurements
OG00073
OG001
Week 30 (good response)
ParticipantsOG000292
ParticipantsOG001297
Title
Measurements
OG000101
OG001
Week 30 (moderate response)
ParticipantsOG000292
ParticipantsOG001297
Title
Measurements
OG000133
OG001
Week 30 (no response)
ParticipantsOG000292
ParticipantsOG001297
Title
Measurements
OG00058
OG001
Units
Counts
Participants
OG000280
OG001143
OG002143
Title
Denominators
Categories
Week 38 (good response)
ParticipantsOG000276
ParticipantsOG001141
ParticipantsOG002140
Title
Measurements
OG000110
OG00151
OG00249
Week 38 (moderate response)
ParticipantsOG000276
ParticipantsOG001141
ParticipantsOG002140
Title
Measurements
OG000
Week 38 (no response)
ParticipantsOG000276
ParticipantsOG001141
ParticipantsOG002140
Title
Measurements
OG000
Week 46 (good response)
ParticipantsOG000266
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
Week 46 (moderate response)
ParticipantsOG000266
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
Week 46 (no response)
ParticipantsOG000266
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
Week 54 (good response)
ParticipantsOG000256
ParticipantsOG001129
ParticipantsOG002128
Title
Measurements
OG000
Week 54 (moderate response)
ParticipantsOG000256
ParticipantsOG001129
ParticipantsOG002128
Title
Measurements
OG000
Week 54 (no response)
ParticipantsOG000256
ParticipantsOG001129
ParticipantsOG002128
Title
Measurements
OG000
Units
Counts
Participants
OG000253
OG001126
OG002126
Title
Denominators
Categories
Week 62 (good response)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002124
Title
Measurements
OG000122
OG00150
OG00257
Week 62 (moderate response)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002124
Title
Measurements
OG000
Week 62 (no response)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002124
Title
Measurements
OG000
Week 70 (good response)
ParticipantsOG000244
ParticipantsOG001119
ParticipantsOG002121
Title
Measurements
OG000
Week 70 (moderate response)
ParticipantsOG000244
ParticipantsOG001119
ParticipantsOG002121
Title
Measurements
OG000
Week 70 (no response)
ParticipantsOG000244
ParticipantsOG001119
ParticipantsOG002121
Title
Measurements
OG000
Week 78 (good response)
ParticipantsOG000239
ParticipantsOG001114
ParticipantsOG002118
Title
Measurements
OG000
Week 78 (moderate response)
ParticipantsOG000239
ParticipantsOG001114
ParticipantsOG002118
Title
Measurements
OG000
Week 78 (no response)
ParticipantsOG000239
ParticipantsOG001114
ParticipantsOG002118
Title
Measurements
OG000
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Units
Counts
Participants
OG000323
OG001326
Title
Denominators
Categories
TEAEs
Title
Measurements
OG000185
OG001176
SAEs
Title
Measurements
OG00016
OG00120
Treatment related TEAEs
Title
Measurements
OG00081
OG00175
Treatment related SAEs
Title
Measurements
OG0004
OG0014
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000280
OG001143
OG002143
Title
Denominators
Categories
TEAEs
Title
Measurements
OG000103
OG00148
OG00254
SAEs
Title
Measurements
OG00013
OG00111
OG0024
Treatment related TEAEs
Title
Measurements
OG00032
OG00120
OG00216
Treatment related SAEs
Title
Measurements
OG0002
OG0015
OG0020
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Units
Counts
Participants
OG000253
OG001126
OG002126
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00073
OG00138
OG00237
SAEs
Title
Measurements
OG0003
OG0013
OG0026
Treatment related TEAEs
Title
Measurements
OG00022
OG00110
OG0028
Treatment related SAEs
Title
Measurements
OG0000
OG0011
OG0023
Units
Counts
Participants
OG000323
OG001326
Title
Denominators
Categories
TEAEs (Grade 3)
Title
Measurements
OG00034
OG00134
TEAEs (Grade 4)
Title
Measurements
OG0001
OG0016
TEAEs (Grade 5)
Title
Measurements
OG0002
OG0011
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000280
OG001143
OG002143
Title
Denominators
Categories
TEAEs (Grade 3)
Title
Measurements
OG00017
OG00110
OG0026
TEAEs (Grade 4)
Title
Measurements
OG0003
OG0013
OG0020
TEAEs (Grade 5)
Title
Measurements
OG0001
OG0010
OG0020
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Units
Counts
Participants
OG000253
OG001126
OG002126
Title
Denominators
Categories
TEAEs (Grade 3)
Title
Measurements
OG0004
OG0013
OG0027
TEAEs (Grade 4)
Title
Measurements
OG0001
OG0010
OG0020
TEAEs (Grade 5)
Title
Measurements
OG0000
OG0010
OG0020
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Units
Counts
Participants
OG000321
OG001325
Title
Denominators
Categories
Title
Measurements
OG000245
OG001237
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000279
OG001142
OG002141
Title
Denominators
Categories
Title
Measurements
OG000154
OG00183
OG00263
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Units
Counts
Participants
OG000250
OG001123
OG002126
Title
Denominators
Categories
Title
Measurements
OG000127
OG00172
OG00261
Units
Counts
Participants
OG000321
OG001325
Title
Denominators
Categories
Tender joint count (Baseline)
ParticipantsOG000321
ParticipantsOG001325
Title
Measurements
OG00024.7± 13.90
OG00125.8± 12.89
Tender joint count (Change at Week 2)
ParticipantsOG000319
ParticipantsOG001324
Title
Measurements
OG000-5.9± 8.78
OG001
Tender joint count (Change at Week 4)
ParticipantsOG000317
ParticipantsOG001321
Title
Measurements
OG000-9.5± 10.02
OG001
Tender joint count (Change at Week 6)
ParticipantsOG000313
ParticipantsOG001319
Title
Measurements
OG000-10.6± 11.17
OG001
Tender joint count (Change at Week 12)
ParticipantsOG000311
ParticipantsOG001318
Title
Measurements
OG000-12.1± 11.84
OG001
Tender joint count (Change at Week 14)
ParticipantsOG000311
ParticipantsOG001316
Title
Measurements
OG000-11.8± 12.50
OG001
Tender joint count (Change at Week 22)
ParticipantsOG000301
ParticipantsOG001311
Title
Measurements
OG000-13.2± 12.62
OG001
Tender joint count (Change at Week 30)
ParticipantsOG000294
ParticipantsOG001298
Title
Measurements
OG000-14.4± 13.19
OG001
Swollen joint count (Baseline)
ParticipantsOG000321
ParticipantsOG001325
Title
Measurements
OG00016.1± 9.44
OG001
Swollen joint count (Change at Week 2)
ParticipantsOG000319
ParticipantsOG001324
Title
Measurements
OG000-5.5± 6.89
OG001
Swollen joint count (Change at Week 4)
ParticipantsOG000317
ParticipantsOG001321
Title
Measurements
OG000-7.8± 7.75
OG001
Swollen joint count (Change at Week 6)
ParticipantsOG000313
ParticipantsOG001319
Title
Measurements
OG000-8.6± 7.99
OG001
Swollen joint count (Change at Week 12)
ParticipantsOG000311
ParticipantsOG001318
Title
Measurements
OG000-9.6± 8.61
OG001
Swollen joint count (Change at Week 14)
ParticipantsOG000311
ParticipantsOG001316
Title
Measurements
OG000-9.3± 8.87
OG001
Swollen joint count (Change at Week 22)
ParticipantsOG000301
ParticipantsOG001311
Title
Measurements
OG000-10.5± 8.77
OG001
Swollen joint count (Change at Week 30)
ParticipantsOG000294
ParticipantsOG001298
Title
Measurements
OG000-11.0± 9.33
OG001
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000278
OG001142
OG002141
Title
Denominators
Categories
Tender joint count (Baseline)
ParticipantsOG000278
ParticipantsOG001142
ParticipantsOG002141
Title
Measurements
OG00010.2± 11.74
OG00110.2± 11.96
OG0029.1± 8.89
Tender joint count (Change at Week 38)
ParticipantsOG000277
ParticipantsOG001141
ParticipantsOG002141
Title
Measurements
OG000
Tender joint count (Change at Week 46)
ParticipantsOG000269
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
Tender joint count (Change at Week 54)
ParticipantsOG000260
ParticipantsOG001130
ParticipantsOG002129
Title
Measurements
OG000
Swollen joint count (Baseline)
ParticipantsOG000278
ParticipantsOG001142
ParticipantsOG002141
Title
Measurements
OG000
Swollen joint count (Change at Week 38)
ParticipantsOG000277
ParticipantsOG001141
ParticipantsOG002141
Title
Measurements
OG000
Swollen joint count (Change at Week 46)
ParticipantsOG000269
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
Swollen joint count (Change at Week 54)
ParticipantsOG000260
ParticipantsOG001130
ParticipantsOG002129
Title
Measurements
OG000
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
Units
Counts
Participants
OG000249
OG001123
OG002126
Title
Denominators
Categories
Tender joint count (Baseline)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002126
Title
Measurements
OG0007.5± 9.51
OG0017.5± 9.21
OG0027.4± 7.99
Tender joint count (Change at Week 62)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002124
Title
Measurements
OG000
Tender joint count (Change at Week 70)
ParticipantsOG000244
ParticipantsOG001119
ParticipantsOG002122
Title
Measurements
OG000
Tender joint count (Change at Week 78)
ParticipantsOG000239
ParticipantsOG001116
ParticipantsOG002118
Title
Measurements
OG000
Swollen joint count (Baseline)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002126
Title
Measurements
OG000
Swollen joint count (Change at Week 62)
ParticipantsOG000249
ParticipantsOG001123
ParticipantsOG002124
Title
Measurements
OG000
Swollen joint count (Change at Week 70)
ParticipantsOG000244
ParticipantsOG001119
ParticipantsOG002122
Title
Measurements
OG000
Swollen joint count (Change at Week 78)
ParticipantsOG000239
ParticipantsOG001116
ParticipantsOG002118
Title
Measurements
OG000
OG001
Period 1: Infliximab-EU Remicade (INX)
Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.
Units
Counts
Participants
OG000321
OG001325
Title
Denominators
Categories
PAAP (Baseline)
ParticipantsOG000321
ParticipantsOG001325
Title
Measurements
OG00063.514± 20.5903
OG00163.098± 21.5442
PAAP (Change at Week 2)
ParticipantsOG000320
ParticipantsOG001324
Title
Measurements
OG000-15.724± 21.9589
OG001
PAAP (Change at Week 4)
ParticipantsOG000317
ParticipantsOG001321
Title
Measurements
OG000-21.609± 22.3825
OG001
PAAP (Change at Week 6)
ParticipantsOG000314
ParticipantsOG001320
Title
Measurements
OG000-23.917± 25.0213
OG001
PAAP (Change at Week 12)
ParticipantsOG000311
ParticipantsOG001318
Title
Measurements
OG000-25.364± 25.6602
OG001
PAAP (Change at Week 14)
ParticipantsOG000311
ParticipantsOG001316
Title
Measurements
OG000-26.131± 26.8712
OG001
PAAP (Change at week 22)
ParticipantsOG000301
ParticipantsOG001311
Title
Measurements
OG000-27.844± 27.0039
OG001
PAAP (Change at Week 30)
ParticipantsOG000294
ParticipantsOG001298
Title
Measurements
OG000-29.150± 27.9802
OG001
PGA (Baseline)
ParticipantsOG000321
ParticipantsOG001325
Title
Measurements
OG00065.340± 20.7209
OG001
PGA (Change at Week 2)
ParticipantsOG000320
ParticipantsOG001324
Title
Measurements
OG000-17.262± 22.8767
OG001
PGA (Change at Week 4)
ParticipantsOG000317
ParticipantsOG001321
Title
Measurements
OG000-23.393± 23.3769
OG001
PGA (Change at Week 6)
ParticipantsOG000314
ParticipantsOG001320
Title
Measurements
OG000-25.536± 24.8041
OG001
PGA (Change at Week 12)
ParticipantsOG000311
ParticipantsOG001317
Title
Measurements
OG000-26.882± 25.3270
OG001
PGA (Change at Week 14)
ParticipantsOG000311
ParticipantsOG001316
Title
Measurements
OG000-27.583± 26.7955
OG001
PGA (Change at Week 22)
ParticipantsOG000301
ParticipantsOG001310
Title
Measurements
OG000-28.558± 27.5077
OG001
PGA (Change at Week 30)
ParticipantsOG000294
ParticipantsOG001298
Title
Measurements
OG000-29.186± 28.6488
OG001
PGAA (Baseline)
ParticipantsOG000319
ParticipantsOG001325
Title
Measurements
OG00065.362± 16.2520
OG001
PGAA (Change at Week 2)
ParticipantsOG000318
ParticipantsOG001324
Title
Measurements
OG000-21.913± 18.5574
OG001
PGAA (Change at Week 4)
ParticipantsOG000315
ParticipantsOG001321
Title
Measurements
OG000-29.724± 19.2226
OG001
PGAA (Change at Week 6)
ParticipantsOG000312
ParticipantsOG001320
Title
Measurements
OG000-33.319± 20.1143
OG001
PGAA (Change at Week 12)
ParticipantsOG000310
ParticipantsOG001318
Title
Measurements
OG000-34.827± 19.8162
OG001
PGAA (Change at Week 14)
ParticipantsOG000310
ParticipantsOG001316
Title
Measurements
OG000-35.870± 21.4707
OG001
PGAA (Change at Week 22)
ParticipantsOG000300
ParticipantsOG001311
Title
Measurements
OG000-37.542± 20.8619
OG001
PGAA (Change at Week 30)
ParticipantsOG000293
ParticipantsOG001298
Title
Measurements
OG000-39.842± 22.0276
OG001
OG001
Period 2: INX/INX
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
OG002
Period 2: INX/PF-06438179
Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.
Units
Counts
Participants
OG000278
OG001142
OG002141
Title
Denominators
Categories
PAAP (Baseline)
ParticipantsOG000278
ParticipantsOG001142
ParticipantsOG002141
Title
Measurements
OG00033.137± 24.2922
OG00133.331± 22.2738
OG00232.559± 22.2702
PAAP (Change at Week 38)
ParticipantsOG000277
ParticipantsOG001141
ParticipantsOG002141
Title
Measurements
OG000
PAAP (Change at Week 46)
ParticipantsOG000269
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
PAAP (Change at Week 54)
ParticipantsOG000259
ParticipantsOG001130
ParticipantsOG002129
Title
Measurements
OG000
PGA (Baseline)
ParticipantsOG000278
ParticipantsOG001142
ParticipantsOG002141
Title
Measurements
OG000
PGA (Change at Week 38)
ParticipantsOG000277
ParticipantsOG001141
ParticipantsOG002141
Title
Measurements
OG000
PGA (Change at Week 46)
ParticipantsOG000269
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
PGA (Change at Week 54)
ParticipantsOG000259
ParticipantsOG001130
ParticipantsOG002129
Title
Measurements
OG000
PGAA (Baseline)
ParticipantsOG000278
ParticipantsOG001142
ParticipantsOG002141
Title
Measurements
OG000
PGAA (Change at Week 38)
ParticipantsOG000277
ParticipantsOG001141
ParticipantsOG002141
Title
Measurements
OG000
PGAA (Change at Week 46)
ParticipantsOG000269
ParticipantsOG001138
ParticipantsOG002133
Title
Measurements
OG000
PGAA (Change at Week 54)
ParticipantsOG000258
ParticipantsOG001130
ParticipantsOG002129
Title
Measurements
OG000
OG001
Period 3: INX/INX/PF-06438179
Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.
OG002
Period 3: INX/PF-06438179/PF-06438179
Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.