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NCT02097745 · FLOW

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A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies · Source last updated 2016-11-03

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 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
    id
    FG000
    title
    Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        14
      type
      Failure to Return
    4. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Administrative/Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        96
      type
      Reason Not Specified
    milestones
    1. achievements
      1. comment
        Six participants did not receive any treatment and were not included in any analyses.
        group Id
        FG000
        num Subjects
        335
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        157
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        178
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
    id
    FG000
    title
    Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        14
      type
      Failure to Return
    4. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Administrative/Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        96
      type
      Reason Not Specified
    milestones
    1. achievements
      1. comment
        Six participants did not receive any treatment and were not included in any analyses.
        group Id
        FG000
        num Subjects
        335
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        157
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        178
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice