{"groups":[{"description":"Eligible participants were administered the placebo by intravenous infusion on Days 1 and 15 along with methotrexate (MTX) 10-25 milligrams (mg) per os (p.o.) or parenterally once a week up to Week 24 and were followed up to Week 104.","id":"FG000","title":"Placebo Plus Methotrexate"},{"description":"Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.","id":"FG001","title":"Rituximab Plus Methotrexate"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"83"},{"groupId":"FG001","numSubjects":"37"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}],"type":"Refused treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"8"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Failure to return"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Rescue therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Incorrect diagnosis and treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Due to clinical hold"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Went onto rescue therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Participant unblinded (clinical hold)"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"208"},{"groupId":"FG001","numSubjects":"308"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"111"},{"groupId":"FG001","numSubjects":"253"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"55"}],"type":"NOT COMPLETED"}],"title":"Week 24 Analysis"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"12"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"7"}],"type":"Refused treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Failure to return"},{"reasons":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"183"}],"type":"Movement into re-treatment study"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"14"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Participants who completed/not completed Week (W) 24 analysis were entered in W24 to W104 analysis.","groupId":"FG000","numSubjects":"208"},{"comment":"Participants who completed/not completed W24 analysis were entered in W24 to W104 analysis.","groupId":"FG001","numSubjects":"308"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"103"},{"groupId":"FG001","numSubjects":"83"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"105"},{"groupId":"FG001","numSubjects":"225"}],"type":"NOT COMPLETED"}],"title":"Week 24 to Week 104 Analysis"}],"preAssignmentDetails":"Of the total randomized 520 participants who met the eligibility criteria, four did not receive the study treatment and were not included in any analysis population.","recruitmentDetails":"A total of 520 participants were enrolled in the study conducted from 02 May 2003 and 12 July 2012 in 11 countries."}