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NCT02383589 · FLOW

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A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV) · Source last updated 2020-11-10

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

groups
  1. description
    Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
    id
    FG000
    title
    Rituximab (RTX)
  2. description
    Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
    id
    FG001
    title
    Mycophenolate Mofetil (MMF)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Non-compliance with study drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        68
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        58
      comment
      Completed the 52-week treatment period and entered safety follow up (SFU)
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Treated by not accepted treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        58
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        53
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Safety Follow-up (SFU)
Complete source fields
groups
  1. description
    Participants received rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants also received MMF matching placebo orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
    id
    FG000
    title
    Rituximab (RTX)
  2. description
    Participants received Mycophenolate Mofetil (MMF) orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants also received rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria had been met. Participants who withdrew from the treatment period or who completed the total 52-week treatment period entered the safety follow up (SFU) period, and they were observed for 1 year and did not receive any further study treatment.
    id
    FG001
    title
    Mycophenolate Mofetil (MMF)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Non-compliance with study drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        68
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        58
      comment
      Completed the 52-week treatment period and entered safety follow up (SFU)
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Treated by not accepted treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        58
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        53
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Safety Follow-up (SFU)

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Preserved source evidence · Not medical advice