{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"2.4"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"8.7"}]}],"title":"Day 1 Postdose (n=118,109,85,5,23)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Day 15 Predose (n=127,114,87,5,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Day 15 Postdose (n=121,108,89,6,23)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 4 (n=127,111,87,6,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 8 (n=126,111,90,6,23)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"0.9"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 16 (n=122,112,91,6,23)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7.0"},{"groupId":"OG001","value":"6.5"},{"groupId":"OG002","value":"4.6"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"12.5"}]}],"title":"Wk 24 (n=114,107,87,4,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"2.3"},{"groupId":"OG003","value":"0.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 28 (n=121,103,86,6,25)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"0.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"20.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 32 (n=122,107,88,5,24)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"1.0"},{"groupId":"OG002","value":"0.0"},{"groupId":"OG003","value":"50.0"},{"groupId":"OG004","value":"0.0"}]}],"title":"Wk 40 (n=118,103,84,4,23)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.9"},{"groupId":"OG001","value":"1.9"},{"groupId":"OG002","value":"5.6"},{"groupId":"OG003","value":"50.0"},{"groupId":"OG004","value":"13.6"}]}],"title":"Wk 48 (n=118,105,89,4,22)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"114"},{"groupId":"OG002","value":"91"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"24"}],"units":"Participants"}],"description":"Surface expression of CD19 was assessed by FACS analysis as a marker of absolute B lymphocyte count. The LLN was defined as \\< 80 cells/µL.","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":"ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.","reportingStatus":"POSTED","timeFrame":"BL, Days 1 and 15, Weeks 4, 8, 16, 24, 28, 32, 40, and 48","title":"Percentage of Participants With Peripheral CD19+ B Cell Counts Above BL or the Lower Limit of Normal (LLN)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}