A Study to Evaluate Ocrelizumab Compared With Placebo in... | NCT00673920 | Trialant
NCT00673920
Sponsor
Genentech, Inc.
Status
Terminated
Last Update Posted
Dec 4, 2020Actual
Enrollment
314Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
Methotrexate
Ocrelizumab
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00673920
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ACT4394g
Secondary IDs
ID
Type
Description
Link
WA20496
Brief Title
A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
Official Title
A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
Acronym
FEATURE
Organization
Genentech, Inc.INDUSTRY
Status Module
Record Verification Date
Nov 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.
Expanded Access Info
No
Start Date
Apr 24, 2008Actual
Primary Completion Date
Oct 26, 2009Actual
Completion Date
Oct 26, 2009Actual
First Submitted Date
May 5, 2008
First Submission Date that Met QC Criteria
May 5, 2008
First Posted Date
May 7, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 27, 2020
Results First Submitted that Met QC Criteria
Nov 10, 2020
Results First Posted Date
Dec 4, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 28, 2013
Certification/Extension First Submitted that Passed QC Review
Jun 28, 2013
Certification/Extension First Posted Date
Jul 4, 2013Estimated
Last Update Submitted Date
Nov 10, 2020
Last Update Posted Date
Dec 4, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Genentech, Inc.INDUSTRY
Collaborators
Name
Class
Roche Pharma AG
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
RA
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
314Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
Drug: Methotrexate
Drug: Placebo
Ocrelizumab 400mg
Experimental
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
Drug: Methotrexate
Drug: Ocrelizumab
Ocrelizumab 200mg
Experimental
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
Drug: Methotrexate
Drug: Ocrelizumab
Ocrelizumab 200mg/ Ocrelizumab 200mg
Experimental
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
Drug: Methotrexate
Drug: Ocrelizumab
Ocrelizumab 200mg/ Ocrelizumab 400mg
Experimental
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Methotrexate
Drug
Oral or parenteral repeating dose
Ocrelizumab 200mg
Ocrelizumab 200mg/ Ocrelizumab 200mg
Ocrelizumab 200mg/ Ocrelizumab 400mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With American College of Rheumatology (ACR) 20 Response
ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.
The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Adult patients, ≥ 18 years of age
Active rheumatoid arthritis
Inadequate treatment with any DMARD other than methotrexate
Exclusion criteria:
Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
Concurrent treatment with any DMARD other than methotrexate
Previous treatment with any cell-depleting therapies
Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline
Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.
Screening was completed within 28 days prior to randomization. This may have been extended by an additional 56 days, up to a maximum of 84 days, if washout from the respective disease modifying anti-rheumatic drugs (DMARDs) or if immunization was required.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
FG001
Periods
Title
Milestones
Reasons Not Completed
Baseline up to Week 48
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0.05
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Methotrexate
Drug: Ocrelizumab
Ocrelizumab 400mg/ Ocrelizumab 400mg
Experimental
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Drug: Methotrexate
Drug: Ocrelizumab
Placebo/ Ocrelizumab 200mg
Experimental
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
Drug: Methotrexate
Drug: Ocrelizumab
Drug: Placebo
Placebo/ Ocrelizumab 400mg
Experimental
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Drug: Methotrexate
Drug: Ocrelizumab
Drug: Placebo
Ocrelizumab 400mg
Ocrelizumab 400mg/ Ocrelizumab 400mg
Placebo
Placebo/ Ocrelizumab 200mg
Placebo/ Ocrelizumab 400mg
Ocrelizumab
Drug
Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).
Ocrelizumab was administered in combination with Methotrexate.
Ocrelizumab 200mg
Ocrelizumab 200mg/ Ocrelizumab 200mg
Ocrelizumab 200mg/ Ocrelizumab 400mg
Ocrelizumab 400mg
Ocrelizumab 400mg/ Ocrelizumab 400mg
Placebo/ Ocrelizumab 200mg
Placebo/ Ocrelizumab 400mg
Placebo
Drug
Intravenous repeating dose
Placebo
Placebo/ Ocrelizumab 200mg
Placebo/ Ocrelizumab 400mg
Week 24
Change in DAS28 From Baseline
The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity. The change is the difference in adjusted mean change from baseline in DAS28 between ocrelizumab 400 x 1 and ocrelizumab 200 x 2 with placebo.
Week 24
European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders)
Week 24
Percentage of Participants Achieving an ACR50 Response
The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Week 24
Percentage of Participants Achieving an ACR70 Response
The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set
Change in the scores of the following parameters of ACR core set relative to respective baseline scores was measured: SJC (28 and 66 joints) and TJC (28 and 66 joints), patient's global assessment and physician's global assessment based on disease activity (both are expressed by VAS [0 = no disease activity to 100 = maximum disease activity]), HAQ (based on HAQ disability index [HAQDI]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain).
Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration
Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR)
Week 24
Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score
Week 24
Change in SF-36 Subscale and Summary Scores From Baseline
Change in FACIT-F Fatigue Assessment From Baseline
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.
Baseline, Weeks 4, 12, and 24
Percentage of Participants Achieving an ACR20 Response
ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.
Week 48
Percentage of Participants Achieving an ACR50 Response
The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Week 48
Percentage of Participants Achieving an ACR70 Response
The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Week 48
Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6)
Week 48
Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion
Week 24, 48
Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion
Day 15 of Cycles 1 and 2
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
FG002
Ocrelizumab 200mg
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
FG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
FG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
FG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
FG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
FG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
FG00064 subjects
FG001117 subjects
FG002133 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG00060 subjects
FG001114 subjects
FG002126 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0027 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Withdrew consent
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Refused treatment
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Insufficient therapeutic response
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Violation of selection criteria at entry
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Administrative/Other
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Adverse event/intercurrent illness
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Week 24 to Week 48
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00361 subjects
FG00461 subjects
FG005109 subjects
FG00629 subjects
FG00728 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00360 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse event/intercurrent illness
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline characteristics not provided for Participants who were re-randomized at Week 24 (Cycle 2)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
BG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
BG002
Ocrelizumab 200mg
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
BG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
BG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
BG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
BG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
BG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00064
BG001117
BG002131
BG0030
BG0040
BG0050
BG0060
BG0070
BG008312
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
BG00053.1± 11.45
BG00152.3± 11.14
BG00253.0± 11.15
BG008
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00056
BG00193
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00010
BG00122
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0003
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With American College of Rheumatology (ACR) 20 Response
ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.
ITT Population (original randomization)
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.
ITT Population (original randomization)
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Secondary
Change in DAS28 From Baseline
The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity. The change is the difference in adjusted mean change from baseline in DAS28 between ocrelizumab 400 x 1 and ocrelizumab 200 x 2 with placebo.
ITT Population (original randomization)
Posted
Mean
Standard Deviation
Units on scale
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
Secondary
European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders)
ITT Population (original randomization)
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
Secondary
Percentage of Participants Achieving an ACR50 Response
The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
ITT Population (original randomization)
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Secondary
Percentage of Participants Achieving an ACR70 Response
The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
ITT Population (original randomization)
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Secondary
Change From Baseline in the Individual Parameters of the ACR Core Set
Change in the scores of the following parameters of ACR core set relative to respective baseline scores was measured: SJC (28 and 66 joints) and TJC (28 and 66 joints), patient's global assessment and physician's global assessment based on disease activity (both are expressed by VAS [0 = no disease activity to 100 = maximum disease activity]), HAQ (based on HAQ disability index [HAQDI]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain).
ITT Population (original randomization)
Posted
Number
Units on a scale
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
Secondary
Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration
ITT Population (original randomization)
Posted
Number
mg/dL
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
Secondary
Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR)
ITT Population (original randomization)
Posted
Number
mm/hr
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
Secondary
Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score
ITT Population (original randomization)
Posted
Number
95% Confidence Interval
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
Secondary
Change in SF-36 Subscale and Summary Scores From Baseline
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
Secondary
Change in FACIT-F Fatigue Assessment From Baseline
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.
ITT Population (original randomization)
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Weeks 4, 12, and 24
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
Secondary
Percentage of Participants Achieving an ACR20 Response
ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale [VAS]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.
Study extension period included all participants who were re-randomized at Week 24.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
Secondary
Percentage of Participants Achieving an ACR50 Response
The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Study extension period included all participants who were re-randomized at Week 24.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Secondary
Percentage of Participants Achieving an ACR70 Response
The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Study extension period included all participants who were re-randomized at Week 24.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Secondary
Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6)
Study extension period included all participants who were re-randomized at Week 24.
Posted
Number
Percentage of Participants
Week 48
ID
Title
Description
OG000
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
OG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
Secondary
Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion
Placebo population was excluded from the analysis.
Posted
Mean
Standard Deviation
μg/mL
Week 24, 48
ID
Title
Description
OG000
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG001
Ocrelizumab 200mg - Cycle 2
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate in Cycle 2
OG002
Ocrelizumab 400mg - Cycle 1
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
OG003
Ocrelizumab 400mg - Cycle 2
Participants who received a single infusion of 400 mg Ocrelizumab + Methotraxate in Cycle 2
Units
Secondary
Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion
Population included all participants who received second Ocrelizumab infusion.
Posted
Mean
Standard Deviation
μg/mL
Day 15 of Cycles 1 and 2
ID
Title
Description
OG000
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG001
Ocrelizumab 200mg - Cycle 2
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate in Cycle 2
Units
Counts
Participants
OG000
Time Frame
From baseline up to 17 months
Description
Re-randomized Safety Population: All patients (including those not re-randomized at Week 24) who received any part of the second course and provided at least one assessment of safety prior to Week 48 were included in the Re-randomized Safety Population.
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
Placebo
Participants received matching placebo:
on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)
0
64
5
64
32
64
EG001
Ocrelizumab 400mg
Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.
0
117
3
117
59
117
EG002
Ocrelizumab 200mg
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
0
131
2
131
80
131
EG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
0
61
5
61
46
61
EG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
0
61
5
61
49
61
EG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
1
109
10
109
86
109
EG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
0
29
3
29
20
29
EG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
0
28
0
28
22
28
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
BRONCHIECTASIS
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0002 events2 affected64 at risk
EG0013 events3 affected117 at risk
EG0021 events1 affected131 at risk
EG0035 events5 affected61 at risk
EG0045 events5 affected61 at risk
EG0059 events9 affected109 at risk
EG0063 events3 affected29 at risk
EG0070 events0 affected28 at risk
MYCOBACTERIUM ABSCESSUS INFECTION
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected131 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected131 at risk
EG003
COLITIS ULCERATIVE
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0001 events1 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedRA 12.1
Systematic Assessment
EG0001 events1 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
CELLULITIS
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0001 events1 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
PNEUMONIA
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected131 at risk
EG003
PROSTATE INFECTION
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected131 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected131 at risk
EG003
UTERINE LEIOMYOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedRA 12.1
Systematic Assessment
EG0001 events1 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
DEPRESSION
Psychiatric disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0021 events1 affected131 at risk
EG003
COLITIS
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
COLITIS ISCHAEMIC
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
DIVERTICULAR PERFORATION
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
ESCHERICHIA URINARY TRACT INFECTION
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
PYELONEPHRITIS
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
BASAL CELL CARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
MALIGNANT MELANOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
PROSTATE CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
ATRIAL FIBRILLATION
Cardiac disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
MYOCARDIAL INFARCTION
Cardiac disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
CATARACT
Eye disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
CHEST PAIN
General disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
PNEUMOTHORAX
Respiratory, thoracic and mediastinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
ANGINA PECTORIS
Cardiac disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0011 events1 affected117 at risk
EG0020 events0 affected131 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0005 events5 affected64 at risk
EG00112 events12 affected117 at risk
EG00216 events16 affected131 at risk
EG0035 events5 affected61 at risk
EG00414 events14 affected61 at risk
EG00514 events14 affected109 at risk
EG0062 events2 affected29 at risk
EG0074 events4 affected28 at risk
URINARY TRACT INFECTION
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0005 events5 affected64 at risk
EG0013 events3 affected117 at risk
EG0027 events7 affected131 at risk
EG003
BRONCHITIS
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
SINUSITIS
Infections and infestations
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
INFUSION RELATED REACTION
General disorders
MedRA 12.1
Systematic Assessment
EG0007 events7 affected64 at risk
EG00125 events25 affected117 at risk
EG00228 events28 affected131 at risk
EG003
FATIGUE
General disorders
MedRA 12.1
Systematic Assessment
EG0004 events4 affected64 at risk
EG0014 events4 affected117 at risk
EG0022 events2 affected131 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0003 events3 affected64 at risk
EG0014 events4 affected117 at risk
EG00210 events10 affected131 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0004 events4 affected64 at risk
EG0016 events6 affected117 at risk
EG0023 events3 affected131 at risk
EG003
VOMITING
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
HEADACHE
Nervous system disorders
MedRA 12.1
Systematic Assessment
EG0004 events4 affected64 at risk
EG0015 events5 affected117 at risk
EG0027 events7 affected131 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
JOINT INJURY
Injury, poisoning and procedural complications
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0020 events0 affected131 at risk
EG003
HYPERTENSION
Vascular disorders
MedRA 12.1
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected117 at risk
EG0027 events7 affected131 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Communications
Hoffmann-La Roche
800-821-8590
genentech@druginfo.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
D008727
Methotrexate
C533411
ocrelizumab
Ancestor Terms
ID
Term
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
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0 subjects
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FG0070 subjects
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FG0060 subjects
FG0070 subjects
61 subjects
FG005106 subjects
FG00628 subjects
FG00728 subjects
0 subjects
FG0053 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Failure to return
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Insufficient therapeutic response
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
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Adminstrative/Other
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52.8
± 11.2
105
BG008254
Male
BG0008
BG00124
BG00226
BG00858
24
BG00856
Not Hispanic or Latino
BG00054
BG00195
BG002107
BG008256
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0080
2
BG0088
Asian
BG0004
BG00113
BG00210
BG00827
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0080
Black or African American
BG0009
BG0019
BG0029
BG00827
White
BG00044
BG00185
BG00299
BG008228
More than one race
BG0000
BG0010
BG0020
BG0080
Unknown or Not Reported
BG0004
BG0017
BG00211
BG00822
0
OG0040
OG0050
OG0060
OG0070
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG0003.1
OG0014.3
OG0025.3
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00049
OG001104
OG002119
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG000-0.79± 1.293
OG001-1.60± 1.374
OG002-1.67± 1.320
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Week 4 No Response
Title
Measurements
OG00062.5
OG00162.4
OG00258.0
Week 4 Moderate Response
Title
Measurements
OG00037.5
OG00133.3
OG00238.9
Week 4 Good Response
Title
Measurements
OG0000
OG0014.3
OG0023.1
Week 8 No Response
Title
Measurements
OG00070.3
OG00152.1
OG00248.1
Week 8 Moderate Response
Title
Measurements
OG00028.1
OG00139.3
OG00242.0
Week 8 Good Response
Title
Measurements
OG0001.6
OG0018.5
OG0029.9
Week 12 No Response
Title
Measurements
OG00068.8
OG00141.9
OG00235.9
Week 12 Moderate Response
Title
Measurements
OG00029.7
OG00149.6
OG00254.2
Week 12 Good Response
Title
Measurements
OG0001.6
OG00111.1
OG0029.9
Week 16 No Response
Title
Measurements
OG00068.8
OG00139.3
OG00235.1
Week 16 Moderate Response
Title
Measurements
OG00029.7
OG00149.6
OG00247.3
Week 16 Good Response
Title
Measurements
OG0001.6
OG00111.1
OG00217.6
Week 20 No Response
Title
Measurements
OG00068.8
OG00141.0
OG00230.5
Week 20 Moderate Response
Title
Measurements
OG00026.6
OG00148.7
OG00251.1
Week 20 Good Response
Title
Measurements
OG0004.7
OG00110.3
OG00218.3
Week 24 No Response
Title
Measurements
OG00073.4
OG00144.4
OG00238.9
Week 24 Moderate Response
Title
Measurements
OG00021.9
OG00141.0
OG00247.3
Week 24 Good Response
Title
Measurements
OG0004.7
OG00114.5
OG00213.7
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG0007.8
OG00118.8
OG00230.5
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG0001.6
OG0016.8
OG0027.6
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
SJC
Title
Measurements
OG000-4.6
OG001-7.5
OG002-8.7
TJC
Title
Measurements
OG000-8.2
OG001-10.2
OG002-12.0
Patient's global assessment
Title
Measurements
OG000-7.6
OG001-21.2
OG002-24.3
Physician's global assessment
Title
Measurements
OG000-16.0
OG001-24.3
OG002-26.0
Patient's pain assessment
Title
Measurements
OG000-8.0
OG001-17.2
OG002-21.0
HAQ-DI
Title
Measurements
OG000-0.2
OG001-0.4
OG002-0.5
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG000-0.2
OG001-1.0
OG002-0.8
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG000-3.0
OG001-14.2
OG002-11.1
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Title
Measurements
OG00037.5(25.6 to 49.4)
OG00155.6(46.6 to 64.6)
OG00258.8(50.3 to 67.2)
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Mental Component Summary Category Improved
Title
Measurements
OG00042.0
OG00134.9
OG00236.6
Mental Component Summary Category Unchanged
Title
Measurements
OG00038.0
OG00150.0
OG00251.2
Mental Component Summary Category Worsened
Title
Measurements
OG00020.0
OG00115.1
OG00212.2
Physical Component Improved
Title
Measurements
OG00044.0
OG00145.3
OG00253.7
Physical Component Unchanged
Title
Measurements
OG00042.0
OG00151.9
OG00242.3
Physical Component Worsened
Title
Measurements
OG00014.0
OG0012.8
OG0024.1
OG002
Ocrelizumab 200mg - Cycle 1
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG00064
OG001117
OG002131
OG0030
OG0040
OG0050
OG0060
OG0070
Title
Denominators
Categories
Baseline
ParticipantsOG00063
ParticipantsOG001117
ParticipantsOG002130
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00025.13± 10.616
OG00125.33± 11.313
OG00224.74± 11.161
Week 4
ParticipantsOG00063
ParticipantsOG001117
ParticipantsOG002131
ParticipantsOG0030
Week 12
ParticipantsOG00055
ParticipantsOG001114
ParticipantsOG002128
ParticipantsOG0030
Week 24
ParticipantsOG00050
ParticipantsOG001108
ParticipantsOG002127
ParticipantsOG0030
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG0000
OG0010
OG0020
OG00361
OG00461
OG005109
OG00629
OG00728
Title
Denominators
Categories
Title
Measurements
OG00359.0
OG00454.1
OG00556.9
OG00644.8
OG00742.9
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG0000
OG0010
OG0020
OG00361
OG00461
OG005109
OG00629
OG00728
Title
Denominators
Categories
Title
Measurements
OG00336.1
OG00427.9
OG00534.9
OG00620.7
OG00714.3
Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.
OG003
Ocrelizumab 200mg/ Ocrelizumab 200mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
Units
Counts
Participants
OG0000
OG0010
OG0020
OG00361
OG00461
OG005109
OG00629
OG00728
Title
Denominators
Categories
Title
Measurements
OG00319.7
OG00416.4
OG00519.3
OG0066.9
OG0077.1
OG004
Ocrelizumab 200mg/ Ocrelizumab 400mg
Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG005
Ocrelizumab 400mg/ Ocrelizumab 400mg
Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2
OG006
Placebo/ Ocrelizumab 200mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2
OG007
Placebo/ Ocrelizumab 400mg
Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2