{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.63","value":"11.1"},{"groupId":"OG001","spread":"31.63","value":"23.7"},{"groupId":"OG002","spread":"33.09","value":"22.8"}]}],"title":"Physical Component: Week 24 [N=147, 152, 155]"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.99","value":"21.3"},{"groupId":"OG001","spread":"35.81","value":"26.4"},{"groupId":"OG002","spread":"31.93","value":"27.4"}]}],"title":"Physical Component: Week 48 [N=154, 154, 162]"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.43","value":"8.4"},{"groupId":"OG001","spread":"29.13","value":"12.6"},{"groupId":"OG002","spread":"56.64","value":"19.6"}]}],"title":"Mental Component: Week 24 [N=147, 152, 155]"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.52","value":"12.7"},{"groupId":"OG001","spread":"38.87","value":"18.4"},{"groupId":"OG002","spread":"57.34","value":"18.7"}]}],"title":"Mental Component: Week 48 [N=154, 154, 162]"}],"denoms":[{"counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"170"}],"units":"Participants"}],"description":"The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning.\n\nThe percentage change from baseline at each post-baseline visit was calculated as:\n\n\\[(post-baseline value minus baseline value) divided by Baseline value\\]\\*100.\n\nA positive percentage 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":"Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components)","type":"SECONDARY","unitOfMeasure":"percent change"}