{"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":"FG000","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":"FG001","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":"FG002","title":"Rituximab (1.0 g x 2) + Methotrexate"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"7"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"34"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"8"}],"type":"Insufficient therapeutic response"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"8"}],"type":"Failure to return"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Violation of selection criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Refused treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"9"}],"type":"Withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","numSubjects":"120"},{"groupId":"FG002","numSubjects":"137"}],"type":"Administrative reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"251"},{"groupId":"FG001","numSubjects":"252"},{"groupId":"FG002","numSubjects":"252"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"249"},{"groupId":"FG001","numSubjects":"249"},{"groupId":"FG002","numSubjects":"250"}],"type":"Safety/ITT: Received Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"227"},{"groupId":"FG001","numSubjects":"240"},{"groupId":"FG002","numSubjects":"241"}],"type":"Completed Week 24"},{"achievements":[{"groupId":"FG000","numSubjects":"213"},{"groupId":"FG001","numSubjects":"227"},{"groupId":"FG002","numSubjects":"232"}],"type":"Completed Week 52"},{"achievements":[{"groupId":"FG000","numSubjects":"178"},{"groupId":"FG001","numSubjects":"213"},{"groupId":"FG002","numSubjects":"216"}],"type":"Completed Week 104"},{"achievements":[{"comment":"Completed Week 152","groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"80"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"189"},{"groupId":"FG001","numSubjects":"175"},{"groupId":"FG002","numSubjects":"172"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"20"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"11"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"5"}],"type":"Administrative reasons"}],"milestones":[{"achievements":[{"comment":"All participants who received treatment were to enter SFU even if withdrawn during treatment period.","groupId":"FG000","numSubjects":"184"},{"comment":"All participants who received treatment were to enter SFU even if withdrawn during treatment period.","groupId":"FG001","numSubjects":"212"},{"comment":"All participants who received treatment were to enter SFU even if withdrawn during treatment period.","groupId":"FG002","numSubjects":"213"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"129"},{"groupId":"FG001","numSubjects":"171"},{"groupId":"FG002","numSubjects":"176"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"55"},{"groupId":"FG001","numSubjects":"41"},{"groupId":"FG002","numSubjects":"37"}],"type":"NOT COMPLETED"}],"title":"Safety Follow-Up (SFU) Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Administrative reasons"}],"milestones":[{"achievements":[{"comment":"Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.","groupId":"FG000","numSubjects":"34"},{"comment":"Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.","groupId":"FG001","numSubjects":"40"},{"comment":"Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.","groupId":"FG002","numSubjects":"51"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"31"},{"groupId":"FG002","numSubjects":"39"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"12"}],"type":"NOT COMPLETED"}],"title":"Extended Safety Follow-Up (ESFU) Period"}]}