{"analyses":[{"ciPctValue":"95","groupDescription":"Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Secondary endpoint in hierarchical testing structure.","statisticalMethod":"ANOVA"},{"ciPctValue":"95","groupDescription":"Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Secondary endpoint in hierarchical testing structure.","statisticalMethod":"ANOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.7968","value":"-0.806"},{"groupId":"OG001","spread":"0.8142","value":"-1038"},{"groupId":"OG002","spread":"0.7901","value":"-1.055"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"247"},{"groupId":"OG002","value":"248"}],"units":"Participants"}],"description":"The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.","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":"Participants from the Intent-to treat Population includes all randomized participants who received at least one dose of study drug with data at baseline and Week 104 available for analysis. Last observation carried forward.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 104","title":"Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104","type":"SECONDARY","unitOfMeasure":"Score on a scale"}