Intravenous repeating dose

Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "none" [symptom-free and no arthritis symptoms] and the extreme right end "maximum" [maximum arthritis disease activity]; patient assessment of pain in the previous 24 hours on a VAS (extreme left end of the line "none" and the extreme right end "unbearable"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.

A participant was in DAS28 remission if their DAS28 score < 2.6). The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score indicates more disease activity.

Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.

Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.

Total of all reporting groups

Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.

Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.

RP was defined as a change from Baseline in the modified Total Sharp Score (mTSS) ≤ 0. The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.

Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "none" [symptom-free and no arthritis symptoms] and the extreme right end "maximum" [maximum arthritis disease activity]; patient assessment of pain in the previous 24 hours on a VAS (extreme left end of the line "none" and the extreme right end "unbearable"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.

A participant was in DAS28 remission if their DAS28 score < 2.6). The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score indicates more disease activity.

Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants had received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants had received Ocrelizumab intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants had received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76 and ocrelizumab 500 mg intravenously on Weeks 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76 and 78. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.

Participants had received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, 100, 102, 124, and 126. Participants also received methotrexate 20 mg orally per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received acetaminophen 1 g and an antihistamine (diphenhydramine HCl 50 mg or equivalent dose of an alternative) orally 30-60 minutes prior to each infusion of study treatment and methylprednisolone 100 mg intravenously 30 minutes prior to each infusion of study treatment. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone.