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NCT01750697 · FLOW

Participant flow

A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis · Source last updated 2019-06-26

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

groups
  1. description
    Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m\^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))
    id
    FG000
    title
    Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Transferred Back to Local Hospital
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician and Family Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Transferred to Adult Services
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      comment
      Remission Induction Phase (Day 1 to Month 6)
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        25
      comment
      Remission Induction Phase (Day 1 to Month 6)
      type
      Completed
    3. achievements
      1. comment
        Completed required follow-up
        group Id
        FG000
        num Subjects
        24
      comment
      (Month 6 to Month 18)
      type
      Follow-up Phase
    4. achievements
      1. comment
        Completed to CCO. 6 participants entered Extended Safety Follow-up, 10 participants completed Study.
        group Id
        FG000
        num Subjects
        16
      comment
      Completed until CCO (Month 18 up to 4.5 years)
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The screening visit occurred up to 28 days prior to the Day 1 baseline visit. Following successful screening, eligible participants entered the 6 month Remission Induction Phase of the study.
recruitment Details
A total of 25 participants were enrolled in the study over a 3.5 year period from 11 sites across the United Kingdom, Italy, Serbia, Turkey, Canada and the United States.
Complete source fields
groups
  1. description
    Participants received rituximab as an intravenous (IV) infusion of 375 milligrams per meter squared (mg/m\^2) once a week on Days 1, 8, 15 and 22 during the Remission Induction Phase (Day 1 (baseline) to Month 6) and were followed for a minimum of 18 months (maximum 4.5yrs) during the Follow-up Phase until the Common-closeout (CCO))
    id
    FG000
    title
    Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Transferred Back to Local Hospital
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician and Family Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Transferred to Adult Services
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      comment
      Remission Induction Phase (Day 1 to Month 6)
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        25
      comment
      Remission Induction Phase (Day 1 to Month 6)
      type
      Completed
    3. achievements
      1. comment
        Completed required follow-up
        group Id
        FG000
        num Subjects
        24
      comment
      (Month 6 to Month 18)
      type
      Follow-up Phase
    4. achievements
      1. comment
        Completed to CCO. 6 participants entered Extended Safety Follow-up, 10 participants completed Study.
        group Id
        FG000
        num Subjects
        16
      comment
      Completed until CCO (Month 18 up to 4.5 years)
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The screening visit occurred up to 28 days prior to the Day 1 baseline visit. Following successful screening, eligible participants entered the 6 month Remission Induction Phase of the study.
recruitment Details
A total of 25 participants were enrolled in the study over a 3.5 year period from 11 sites across the United Kingdom, Italy, Serbia, Turkey, Canada and the United States.

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Preserved source evidence · Not medical advice