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NCT02093026 · FLOW

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Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) · Source last updated 2017-03-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (\>=) 5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
    id
    FG000
    title
    Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        26
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        157
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        465
      type
      STARTED
    2. achievements
      1. comment
        At predefined end-of-treatment date, 272 ongoing participants were designated as completed study.
        group Id
        FG000
        num Subjects
        272
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        193
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study included participants who had previously participated in studies WA16291 (NCT02693210) or WA17043 (NCT00074438).
Complete source fields
groups
  1. description
    Participants received rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (\>=) 5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
    id
    FG000
    title
    Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        26
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        157
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        465
      type
      STARTED
    2. achievements
      1. comment
        At predefined end-of-treatment date, 272 ongoing participants were designated as completed study.
        group Id
        FG000
        num Subjects
        272
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        193
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study included participants who had previously participated in studies WA16291 (NCT02693210) or WA17043 (NCT00074438).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice