{"analyses":[{"ciPctValue":"95","groupDescription":"Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"This was a secondary endpoint in a hierarchical testing structure.","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciPctValue":"95","groupDescription":"Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"This was a secondary endpoint in a hierarchical testing structure.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41.8"},{"groupId":"OG001","value":"59.4"},{"groupId":"OG002","value":"64.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"250"}],"units":"Participants"}],"description":"To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)","groups":[{"description":"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.","id":"OG000","title":"Placebo + Methotrexate"},{"description":"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6","id":"OG001","title":"Rituximab (0.5 g x 2) + Methotrexate"},{"description":"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6","id":"OG002","title":"Rituximab (1.0 g x 2) + Methotrexate"}],"paramType":"NUMBER","populationDescription":"Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).","reportingStatus":"POSTED","timeFrame":"Week 52","title":"Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}