{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.1"},{"groupId":"OG001","value":"1.9"},{"groupId":"OG002","value":"7.5"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"4.2"}]}],"title":"Wk 24, Negative to Borderline (n=113,107,80,4,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14.2"},{"groupId":"OG001","value":"16.8"},{"groupId":"OG002","value":"11.3"},{"groupId":"OG003","value":"25.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 24, Borderline to Negative (n=113,107,80,4,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.9"},{"groupId":"OG002","value":"1.3"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 24, Borderline to Positive (n=113,107,80,4,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.9"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"6.3"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 24, Positive to Borderline (n=113,107,80,4,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.9"},{"groupId":"OG002","value":"1.3"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 24, Positive to Negative (n=113,107,80,4,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"77.9"},{"groupId":"OG001","value":"79.4"},{"groupId":"OG002","value":"72.5"},{"groupId":"OG003","value":"75.0"},{"groupId":"OG004","value":"95.8"}]}],"title":"Wk 24, Unchanged (n=113,107,80,4,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.7"},{"groupId":"OG001","value":"2.0"},{"groupId":"OG002","value":"2.3"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 48, Negative to Borderline (n=112,102,86,4,22)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23.2"},{"groupId":"OG001","value":"24.5"},{"groupId":"OG002","value":"16.3"},{"groupId":"OG003","value":"50.0"},{"groupId":"OG004","value":"9.1"}]}],"title":"Wk 48, Borderline to Negative (n=112,102,86,4,22)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"1.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 48, Borderline to Positive (n=112,102,86,4,22)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.4"},{"groupId":"OG001","value":"3.9"},{"groupId":"OG002","value":"7.0"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"4.5"}]}],"title":"Wk 48, Positive to Borderline (n=112,102,86,4,22)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.5"},{"groupId":"OG001","value":"2.0"},{"groupId":"OG002","value":"3.5"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 48, Positive to Negative (n=112,102,86,4,22)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64.3"},{"groupId":"OG001","value":"66.7"},{"groupId":"OG002","value":"70.9"},{"groupId":"OG003","value":"50.0"},{"groupId":"OG004","value":"86.4"}]}],"title":"Wk 48, Unchanged (n=112,102,86,4,22)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"107"},{"groupId":"OG002","value":"86"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"24"}],"units":"Participants"}],"description":"ANA titers were obtained by the following serum dilution schema: negative = negative, borderline = 1 diluted to (:) 40 or 1:80, and positive ≥ 1:160. The change categories were defined for the change from BL to Weeks 24 and 48 according to this schema. Negative to borderline was defined as any change from negative to borderline as no dilution is given for negative results. Negative to positive was defined as at least a two-fold positive change in dilution from BL. Borderline to negative was defined as any change from borderline to negative as no dilution is given for negative results. Borderline to positive was defined as at least a two-fold positive change in dilution from BL. Positive to borderline was defined as at least a two-fold negative change in dilution from BL. Positive to negative was defined as at least a two-fold negative change in dilution from BL. Unchanged was defined as any difference in dilution less than two-fold.","groups":[{"description":"Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.","id":"OG000","title":"Rituximab Low Dose + Methotrexate"},{"description":"Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.","id":"OG001","title":"Rituximab Escalated Dose + Methotrexate"},{"description":"Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.","id":"OG002","title":"Rituximab High Dose + Methotrexate"},{"description":"Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.","id":"OG003","title":"Rituximab/Placebo + Methotrexate"},{"description":"Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.","id":"OG004","title":"Rituximab Decreased Dose + Methotrexate"}],"paramType":"NUMBER","populationDescription":"SAP, n=number of participants assessed for the given parameter at the specified timepoint.","reportingStatus":"POSTED","timeFrame":"BL, Weeks 24 and 48","title":"Percentage of Participants With a Change From BL by Category in Anti-Nuclear Antibodies (ANA) Titers","type":"SECONDARY","unitOfMeasure":"percentage of participants"}