{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"54.7"},{"groupId":"OG001","value":"73.3"},{"groupId":"OG002","value":"68.8"}]}],"title":"Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29.1"},{"groupId":"OG001","value":"17.0"},{"groupId":"OG002","value":"25.3"}]}],"title":"No change"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16.3"},{"groupId":"OG001","value":"9.7"},{"groupId":"OG002","value":"5.9"}]}],"title":"Worsened"}],"denoms":[{"counts":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"170"}],"units":"Participants"}],"description":"The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement.\n\nImproved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22.\n\nAn Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22.\n\nA worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22.","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":"NUMBER","populationDescription":"Intent-to-treat population including participants with available data. LOCF was used.","reportingStatus":"POSTED","timeFrame":"Baseline and Week 48","title":"Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48","type":"SECONDARY","unitOfMeasure":"percentage of participants"}