{"analyses":[{"ciPctValue":"95","groupDescription":"Comparing all three treatment groups","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0016","pValueComment":"The Closure Principle was used to adjust for multiple comparisons.","statisticalMethod":"Kruskal-Wallis"},{"ciPctValue":"95","groupDescription":"Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1824","pValueComment":"The Closure Principle was used to adjust for multiple comparisons.","statisticalMethod":"Van-Elteren"},{"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":"0.0004","pValueComment":"The Closure Principle was used to adjust for multiple comparisons.","statisticalMethod":"Van-Elteren"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.0934","value":"1.079"},{"groupId":"OG001","spread":"1.9196","value":"0.646"},{"groupId":"OG002","spread":"1.0095","value":"0.359"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"232"},{"groupId":"OG001","value":"239"},{"groupId":"OG002","value":"244"}],"units":"Participants"}],"description":"Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. 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 and higher scores represent a worsening of joint erosions and joint space narrowing.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.","reportingStatus":"POSTED","timeFrame":"Baseline and week 52","title":"Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52","type":"PRIMARY","unitOfMeasure":"Score on a scale"}