{"analyses":[{"ciLowerLimit":"-0.05","ciPctValue":"95","ciUpperLimit":"0.13","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":"0.3803","pValueComment":"This was a secondary endpoint in a hierarchical testing structure.","paramType":"Mean Difference (Net)","paramValue":"0.04","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"0.01","ciPctValue":"95","ciUpperLimit":"0.18","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":"0.0309","pValueComment":"This was a secondary endpoint in a hierarchical testing structure.","paramType":"Mean Difference (Net)","paramValue":"0.10","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"53.4"},{"groupId":"OG001","value":"57.7"},{"groupId":"OG002","value":"63.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"239"},{"groupId":"OG002","value":"244"}],"units":"Participants"}],"description":"Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) \\<= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.","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":"Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 52","title":"Percentage of Patients Without Radiographic Progression at Week 52","type":"SECONDARY","unitOfMeasure":"Percentage"}