{"groups":[{"description":"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.\n\nAll participants entered a 48-week safety follow-up (SFU) period following the treatment period.","id":"FG000","title":"Placebo + MTX"},{"description":"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.\n\nParticipants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.\n\nAll participants entered a 48-week safety follow-up (SFU) period following the treatment period.","id":"FG001","title":"Rituximab 2 x 0.5 g + MTX"},{"description":"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.\n\nParticipants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.\n\nAll participants entered a 48-week safety follow-up (SFU) period following the treatment period.","id":"FG002","title":"Rituximab 2 x 1.0 g + MTX"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"13"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"}],"type":"Insufficient Therapeutic Response"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"19"}],"type":"Refused Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"}],"type":"Failure to Return"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"4"}],"type":"Reason not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"172"},{"groupId":"FG001","numSubjects":"168"},{"groupId":"FG002","numSubjects":"171"}],"type":"STARTED"},{"achievements":[{"comment":"155 participants in placebo arm switched to active therapy (rituximab 2 x 0.5g) between Weeks 16-48.","groupId":"FG000","numSubjects":"172"},{"groupId":"FG001","numSubjects":"167"},{"groupId":"FG002","numSubjects":"170"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"159"},{"groupId":"FG001","numSubjects":"162"},{"groupId":"FG002","numSubjects":"166"}],"type":"Completed 24 Weeks"},{"achievements":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"157"},{"groupId":"FG002","numSubjects":"158"}],"type":"Completed 48 Weeks"},{"achievements":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"138"},{"groupId":"FG002","numSubjects":"132"}],"type":"Completed 144 Weeks"},{"achievements":[{"groupId":"FG000","numSubjects":"119"},{"groupId":"FG001","numSubjects":"125"},{"groupId":"FG002","numSubjects":"121"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"43"},{"groupId":"FG002","numSubjects":"50"}],"type":"NOT COMPLETED"}],"title":"Treatment Period (up to 5 Years)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"4"}],"type":"Administrative/Other"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}],"type":"Did not Co-operate"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"15"}],"type":"Failure to Return"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"No SFU Week 48 Date Recorded"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"21"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"167"},{"groupId":"FG001","numSubjects":"165"},{"groupId":"FG002","numSubjects":"168"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"122"},{"groupId":"FG001","numSubjects":"120"},{"groupId":"FG002","numSubjects":"123"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"45"},{"groupId":"FG001","numSubjects":"45"},{"groupId":"FG002","numSubjects":"45"}],"type":"NOT COMPLETED"}],"title":"Safety Follow-up (SFU) (48 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Failure to Return"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"}],"type":"Did not Cooperate/Withdrew Consent"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"82"},{"groupId":"FG002","numSubjects":"44"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"74"},{"groupId":"FG002","numSubjects":"38"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"Extended SFU (ESFU) (up to 5.1 Years)"}],"preAssignmentDetails":"Of the 509 participants, one participant was randomized first to rituximab 2 x 1.0 g + MTX and then to rituximab 2 x 0.5 g + MTX. No assessments were recorded or medication given after first randomization and all data used in analyses was following the second randomization; hence, participant is included only in rituximab 2 x 0.5 g + MTX arm.","recruitmentDetails":"A total of 511 participants were recruited and randomized between 27 Oct 2005 and 15 Nov 2006. Of these, 2 participants were randomized but received no infusions (one violated inclusion criteria and the other was randomized to rituximab 2 x 1.0 gram \\[g\\] + methotrexate \\[MTX\\] but failed to return). A total of 509 participants were treated."}