{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.5093","value":"2.661"},{"groupId":"OG001","spread":"9.7438","value":"5.564"},{"groupId":"OG002","spread":"10.2143","value":"6.398"}]}],"title":"Week 24 [N=170, 165, 168]"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.9651","value":"5.506"},{"groupId":"OG001","spread":"9.7495","value":"6.269"},{"groupId":"OG002","spread":"9.7833","value":"6.203"}]}],"title":"Week 48 [N=170, 165, 169]"}],"denoms":[{"counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"170"}],"units":"Participants"}],"description":"The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.\n\nA positive change from baseline score indicates an improvement.","dispersionType":"Standard Deviation","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 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":"OG000","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":"OG001","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":"OG002","title":"Rituximab 2 x 1.0 g + MTX"}],"paramType":"MEAN","populationDescription":"Intent-to-treat population, LOCF was used. \"N\" indicates the number of participants with non-missing data at each time point.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 24 and Week 48","title":"Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores","type":"SECONDARY","unitOfMeasure":"scores on a scale"}