Rheumatoid Arthritis
Conditions
Keywords
RA
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.
Interventions
DRUGMethotrexate
Oral or parenteral repeating dose
DRUGOcrelizumab
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.
DRUGPlacebo
Intravenous repeating dose
Sponsors
Roche Pharma AG
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With American College of Rheumatology (ACR) 20 Response | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in DAS28 From Baseline | Week 24 | 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. |
| European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 | — |
| Percentage of Participants Achieving an ACR50 Response | Week 24 | 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). |
| Percentage of Participants Achieving an ACR70 Response | Week 24 | 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). |
| Change From Baseline in the Individual Parameters of the ACR Core Set | Week 24 | 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). |
| 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 Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6) | Week 24 | 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. |
| Change in SF-36 Subscale and Summary Scores From Baseline | Week 24 | Improved, change \> 5.42; Unchanged, -5.42 \<= Change \<= 5.42; Worsened, change \< -5.42 |
| Change in FACIT-F Fatigue Assessment From Baseline | Baseline, Weeks 4, 12, and 24 | 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. |
| Percentage of Participants Achieving an ACR20 Response | Week 48 | 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. |
| 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 | — |
| Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score | Week 24 | — |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 64 |
| Ocrelizumab 400mg Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1. | 117 |
| Ocrelizumab 200mg Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1. | 131 |
| 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 |
| 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 |
| 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 | 0 |
| 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 |
| 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 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Baseline up to Week 48 | Administrative/Other | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Baseline up to Week 48 | Adverse event/intercurrent illness | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Baseline up to Week 48 | Insufficient therapeutic response | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline up to Week 48 | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Baseline up to Week 48 | Refused treatment | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline up to Week 48 | Violation of selection criteria at entry | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Baseline up to Week 48 | Withdrew consent | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Week 24 to Week 48 | Adminstrative/Other | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Week 24 to Week 48 | Adverse event/intercurrent illness | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Week 24 to Week 48 | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Week 24 to Week 48 | Failure to return | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Week 24 to Week 48 | Insufficient therapeutic response | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Ocrelizumab 400mg | Ocrelizumab 200mg | Total |
|---|---|---|---|---|
| Age, Continuous | 53.1 Years STANDARD_DEVIATION 11.45 | 52.3 Years STANDARD_DEVIATION 11.14 | 53.0 Years STANDARD_DEVIATION 11.15 | 52.8 Years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 22 Participants | 24 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 95 Participants | 107 Participants | 256 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 13 Participants | 10 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 9 Participants | 9 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 11 Participants | 22 Participants |
| Race (NIH/OMB) White | 44 Participants | 85 Participants | 99 Participants | 228 Participants |
| Sex: Female, Male Female | 56 Participants | 93 Participants | 105 Participants | 254 Participants |
| Sex: Female, Male Male | 8 Participants | 24 Participants | 26 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 117 | 0 / 131 | 0 / 61 | 0 / 61 | 1 / 109 | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 32 / 64 | 59 / 117 | 80 / 131 | 46 / 61 | 49 / 61 | 86 / 109 | 20 / 29 | 22 / 28 |
| serious Total, serious adverse events | 5 / 64 | 3 / 117 | 2 / 131 | 5 / 61 | 5 / 61 | 10 / 109 | 3 / 29 | 0 / 28 |
Outcome results
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.
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With American College of Rheumatology (ACR) 20 Response | 28.1 Percentage of Participants |
| Ocrelizumab 400mg | Percentage of Participants With American College of Rheumatology (ACR) 20 Response | 37.6 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Percentage of Participants With American College of Rheumatology (ACR) 20 Response | 52.7 Percentage of Participants |
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).
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change From Baseline in the Individual Parameters of the ACR Core Set | TJC | -8.2 Units on a scale |
| Placebo | Change From Baseline in the Individual Parameters of the ACR Core Set | SJC | -4.6 Units on a scale |
| Placebo | Change From Baseline in the Individual Parameters of the ACR Core Set | HAQ-DI | -0.2 Units on a scale |
| Placebo | Change From Baseline in the Individual Parameters of the ACR Core Set | Patient's pain assessment | -8.0 Units on a scale |
| Placebo | Change From Baseline in the Individual Parameters of the ACR Core Set | Physician's global assessment | -16.0 Units on a scale |
| Placebo | Change From Baseline in the Individual Parameters of the ACR Core Set | Patient's global assessment | -7.6 Units on a scale |
| Ocrelizumab 400mg | Change From Baseline in the Individual Parameters of the ACR Core Set | Physician's global assessment | -24.3 Units on a scale |
| Ocrelizumab 400mg | Change From Baseline in the Individual Parameters of the ACR Core Set | HAQ-DI | -0.4 Units on a scale |
| Ocrelizumab 400mg | Change From Baseline in the Individual Parameters of the ACR Core Set | TJC | -10.2 Units on a scale |
| Ocrelizumab 400mg | Change From Baseline in the Individual Parameters of the ACR Core Set | Patient's global assessment | -21.2 Units on a scale |
| Ocrelizumab 400mg | Change From Baseline in the Individual Parameters of the ACR Core Set | SJC | -7.5 Units on a scale |
| Ocrelizumab 400mg | Change From Baseline in the Individual Parameters of the ACR Core Set | Patient's pain assessment | -17.2 Units on a scale |
| Ocrelizumab 200mg - Cycle 1 | Change From Baseline in the Individual Parameters of the ACR Core Set | HAQ-DI | -0.5 Units on a scale |
| Ocrelizumab 200mg - Cycle 1 | Change From Baseline in the Individual Parameters of the ACR Core Set | SJC | -8.7 Units on a scale |
| Ocrelizumab 200mg - Cycle 1 | Change From Baseline in the Individual Parameters of the ACR Core Set | TJC | -12.0 Units on a scale |
| Ocrelizumab 200mg - Cycle 1 | Change From Baseline in the Individual Parameters of the ACR Core Set | Patient's global assessment | -24.3 Units on a scale |
| Ocrelizumab 200mg - Cycle 1 | Change From Baseline in the Individual Parameters of the ACR Core Set | Physician's global assessment | -26.0 Units on a scale |
| Ocrelizumab 200mg - Cycle 1 | Change From Baseline in the Individual Parameters of the ACR Core Set | Patient's pain assessment | -21.0 Units on a scale |
Secondary
Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration | -0.2 mg/dL |
| Ocrelizumab 400mg | Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration | -1.0 mg/dL |
| Ocrelizumab 200mg - Cycle 1 | Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration | -0.8 mg/dL |
Secondary
Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR)
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR) | -3.0 mm/hr |
| Ocrelizumab 400mg | Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR) | -14.2 mm/hr |
| Ocrelizumab 200mg - Cycle 1 | Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR) | -11.1 mm/hr |
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.
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in DAS28 From Baseline | -0.79 Units on scale | Standard Deviation 1.293 |
| Ocrelizumab 400mg | Change in DAS28 From Baseline | -1.60 Units on scale | Standard Deviation 1.374 |
| Ocrelizumab 200mg - Cycle 1 | Change in DAS28 From Baseline | -1.67 Units on scale | Standard Deviation 1.32 |
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.
Time frame: Baseline, Weeks 4, 12, and 24
Population: ITT Population (original randomization)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in FACIT-F Fatigue Assessment From Baseline | Week 4 | 28.94 Units on a scale | Standard Deviation 11.371 |
| Placebo | Change in FACIT-F Fatigue Assessment From Baseline | Week 24 | 28.47 Units on a scale | Standard Deviation 12.406 |
| Placebo | Change in FACIT-F Fatigue Assessment From Baseline | Baseline | 25.13 Units on a scale | Standard Deviation 10.616 |
| Placebo | Change in FACIT-F Fatigue Assessment From Baseline | Week 12 | 28.42 Units on a scale | Standard Deviation 12.015 |
| Ocrelizumab 400mg | Change in FACIT-F Fatigue Assessment From Baseline | Week 4 | 28.60 Units on a scale | Standard Deviation 11.231 |
| Ocrelizumab 400mg | Change in FACIT-F Fatigue Assessment From Baseline | Week 12 | 32.09 Units on a scale | Standard Deviation 12.368 |
| Ocrelizumab 400mg | Change in FACIT-F Fatigue Assessment From Baseline | Week 24 | 31.38 Units on a scale | Standard Deviation 11.346 |
| Ocrelizumab 400mg | Change in FACIT-F Fatigue Assessment From Baseline | Baseline | 25.33 Units on a scale | Standard Deviation 11.313 |
| Ocrelizumab 200mg - Cycle 1 | Change in FACIT-F Fatigue Assessment From Baseline | Week 24 | 33.18 Units on a scale | Standard Deviation 11.011 |
| Ocrelizumab 200mg - Cycle 1 | Change in FACIT-F Fatigue Assessment From Baseline | Baseline | 24.74 Units on a scale | Standard Deviation 11.161 |
| Ocrelizumab 200mg - Cycle 1 | Change in FACIT-F Fatigue Assessment From Baseline | Week 4 | 30.71 Units on a scale | Standard Deviation 11.136 |
| Ocrelizumab 200mg - Cycle 1 | Change in FACIT-F Fatigue Assessment From Baseline | Week 12 | 33.09 Units on a scale | Standard Deviation 10.903 |
Secondary
Change in SF-36 Subscale and Summary Scores From Baseline
Improved, change \> 5.42; Unchanged, -5.42 \<= Change \<= 5.42; Worsened, change \< -5.42
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Improved | 42.0 Percentage of Participants |
| Placebo | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Improved | 44.0 Percentage of Participants |
| Placebo | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Worsened | 20.0 Percentage of Participants |
| Placebo | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Unchanged | 42.0 Percentage of Participants |
| Placebo | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Worsened | 14.0 Percentage of Participants |
| Placebo | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Unchanged | 38.0 Percentage of Participants |
| Ocrelizumab 400mg | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Worsened | 15.1 Percentage of Participants |
| Ocrelizumab 400mg | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Unchanged | 51.9 Percentage of Participants |
| Ocrelizumab 400mg | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Improved | 34.9 Percentage of Participants |
| Ocrelizumab 400mg | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Unchanged | 50.0 Percentage of Participants |
| Ocrelizumab 400mg | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Improved | 45.3 Percentage of Participants |
| Ocrelizumab 400mg | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Worsened | 2.8 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Worsened | 4.1 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Improved | 53.7 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Change in SF-36 Subscale and Summary Scores From Baseline | Physical Component Unchanged | 42.3 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Improved | 36.6 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Worsened | 12.2 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Change in SF-36 Subscale and Summary Scores From Baseline | Mental Component Summary Category Unchanged | 51.2 Percentage of Participants |
Secondary
Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion
Time frame: Week 24, 48
Population: Placebo population was excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion | 73.1 μg/mL | Standard Deviation 63.8 |
| Ocrelizumab 400mg | Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion | 67.7 μg/mL | Standard Deviation 27 |
| Ocrelizumab 200mg - Cycle 1 | Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion | 133 μg/mL | Standard Deviation 38.5 |
| Ocrelizumab 200mg/ Ocrelizumab 200mg | Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion | 137 μg/mL | Standard Deviation 45.4 |
Secondary
Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion
Time frame: Day 15 of Cycles 1 and 2
Population: Population included all participants who received second Ocrelizumab infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion | 71.7 μg/mL | Standard Deviation 18 |
| Ocrelizumab 400mg | Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion | 77.6 μg/mL | Standard Deviation 27.4 |
Secondary
European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders)
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 Moderate Response | 28.1 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 Moderate Response | 37.5 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 Good Response | 0 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 No Response | 70.3 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 No Response | 62.5 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 Good Response | 1.6 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 No Response | 68.8 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 Moderate Response | 29.7 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 Good Response | 1.6 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 No Response | 68.8 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 Moderate Response | 29.7 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 Good Response | 1.6 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 No Response | 68.8 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 Moderate Response | 26.6 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 Good Response | 4.7 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 No Response | 73.4 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 Moderate Response | 21.9 Percentage of Participants |
| Placebo | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 Good Response | 4.7 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 Good Response | 14.5 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 No Response | 62.4 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 No Response | 39.3 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 No Response | 41.0 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 Moderate Response | 33.3 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 Good Response | 10.3 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 No Response | 44.4 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 Good Response | 4.3 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 Moderate Response | 49.6 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 Moderate Response | 41.0 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 No Response | 52.1 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 Good Response | 11.1 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 Moderate Response | 48.7 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 Moderate Response | 39.3 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 Moderate Response | 49.6 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 Good Response | 11.1 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 Good Response | 8.5 Percentage of Participants |
| Ocrelizumab 400mg | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 No Response | 41.9 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 Good Response | 9.9 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 No Response | 35.9 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 Moderate Response | 54.2 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 Good Response | 18.3 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 12 Good Response | 9.9 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 Good Response | 13.7 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 No Response | 35.1 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 Moderate Response | 47.3 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 No Response | 38.9 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 16 Good Response | 17.6 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 No Response | 58.0 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 Moderate Response | 38.9 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 No Response | 30.5 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 4 Good Response | 3.1 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 No Response | 48.1 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 8 Moderate Response | 42.0 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 20 Moderate Response | 51.1 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) | Week 24 Moderate Response | 47.3 Percentage of Participants |
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.
Time frame: Week 48
Population: Study extension period included all participants who were re-randomized at Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocrelizumab 200mg/ Ocrelizumab 200mg | Percentage of Participants Achieving an ACR20 Response | 59.0 Percentage of Participants |
| Ocrelizumab 200mg/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR20 Response | 54.1 Percentage of Participants |
| Ocrelizumab 400mg/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR20 Response | 56.9 Percentage of Participants |
| Placebo/ Ocrelizumab 200mg | Percentage of Participants Achieving an ACR20 Response | 44.8 Percentage of Participants |
| Placebo/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR20 Response | 42.9 Percentage of Participants |
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).
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving an ACR50 Response | 7.8 Percentage of Participants |
| Ocrelizumab 400mg | Percentage of Participants Achieving an ACR50 Response | 18.8 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Percentage of Participants Achieving an ACR50 Response | 30.5 Percentage of Participants |
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).
Time frame: Week 48
Population: Study extension period included all participants who were re-randomized at Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocrelizumab 200mg/ Ocrelizumab 200mg | Percentage of Participants Achieving an ACR50 Response | 36.1 Percentage of Participants |
| Ocrelizumab 200mg/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR50 Response | 27.9 Percentage of Participants |
| Ocrelizumab 400mg/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR50 Response | 34.9 Percentage of Participants |
| Placebo/ Ocrelizumab 200mg | Percentage of Participants Achieving an ACR50 Response | 20.7 Percentage of Participants |
| Placebo/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR50 Response | 14.3 Percentage of Participants |
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).
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving an ACR70 Response | 1.6 Percentage of Participants |
| Ocrelizumab 400mg | Percentage of Participants Achieving an ACR70 Response | 6.8 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Percentage of Participants Achieving an ACR70 Response | 7.6 Percentage of Participants |
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).
Time frame: Week 48
Population: Study extension period included all participants who were re-randomized at Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocrelizumab 200mg/ Ocrelizumab 200mg | Percentage of Participants Achieving an ACR70 Response | 19.7 Percentage of Participants |
| Ocrelizumab 200mg/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR70 Response | 16.4 Percentage of Participants |
| Ocrelizumab 400mg/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR70 Response | 19.3 Percentage of Participants |
| Placebo/ Ocrelizumab 200mg | Percentage of Participants Achieving an ACR70 Response | 6.9 Percentage of Participants |
| Placebo/ Ocrelizumab 400mg | Percentage of Participants Achieving an ACR70 Response | 7.1 Percentage of Participants |
Secondary
Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6)
Time frame: Week 48
Population: Study extension period included all participants who were re-randomized at Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocrelizumab 200mg/ Ocrelizumab 200mg | Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6) | 13.1 Percentage of Participants |
| Ocrelizumab 200mg/ Ocrelizumab 400mg | Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6) | 3.3 Percentage of Participants |
| Ocrelizumab 400mg/ Ocrelizumab 400mg | Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6) | 11.0 Percentage of Participants |
| Placebo/ Ocrelizumab 200mg | Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6) | 6.9 Percentage of Participants |
| Placebo/ Ocrelizumab 400mg | Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6) | 3.6 Percentage of Participants |
Secondary
Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6)
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.
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6) | 3.1 Percentage of Participants |
| Ocrelizumab 400mg | Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6) | 4.3 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6) | 5.3 Percentage of Participants |
Secondary
Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score
Time frame: Week 24
Population: ITT Population (original randomization)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score | 37.5 Percentage of Participants |
| Ocrelizumab 400mg | Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score | 55.6 Percentage of Participants |
| Ocrelizumab 200mg - Cycle 1 | Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score | 58.8 Percentage of Participants |