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NCT02383589 · OUTCOME

Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)

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.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018)

Analysis population: The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug.

Groups in this outcome

Rituximab (RTX)

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.

Mycophenolate Mofetil (MMF)

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Rituximab (RTX)67
Mycophenolate Mofetil (MMF)68

Reported measurements

Baseline (IgA)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)0Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)0Not reportedNot reportedNot reportedNot reported
Week 16 (IgA)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)0Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)1.8Not reportedNot reportedNot reportedNot reported
Week 24 (IgA)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)1.7Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)2.2Not reportedNot reportedNot reportedNot reported
Week 40 (IgA)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)0Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)2.7Not reportedNot reportedNot reportedNot reported
Week 52 (IgA)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)0Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)3.6Not reportedNot reportedNot reportedNot reported
Baseline (IgG)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)6.1Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)6.0Not reportedNot reportedNot reportedNot reported
Week 16 (IgG)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)9.8Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)1.8Not reportedNot reportedNot reportedNot reported
Week 24 (IgG)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)3.4Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)2.2Not reportedNot reportedNot reportedNot reported
Week 40 (IgG)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)3.5Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)0Not reportedNot reportedNot reportedNot reported
Week 52 (IgG)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)4.3Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)0Not reportedNot reportedNot reportedNot reported
Baseline (IgM)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)7.6Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)11.9Not reportedNot reportedNot reportedNot reported
Week 16 (IgM)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)24.6Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)23.2Not reportedNot reportedNot reportedNot reported
Week 24 (IgM)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)27.1Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)28.3Not reportedNot reportedNot reportedNot reported
Week 40 (IgM)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)29.8Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)24.3Not reportedNot reportedNot reportedNot reported
Week 52 (IgM)
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab (RTX)29.8Not reportedNot reportedNot reportedNot reported
Mycophenolate Mofetil (MMF)28.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Baseline (IgA)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1.8
    title
    Week 16 (IgA)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1.7
      2. group Id
        OG001
        value
        2.2
    title
    Week 24 (IgA)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2.7
    title
    Week 40 (IgA)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3.6
    title
    Week 52 (IgA)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6.1
      2. group Id
        OG001
        value
        6.0
    title
    Baseline (IgG)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9.8
      2. group Id
        OG001
        value
        1.8
    title
    Week 16 (IgG)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3.4
      2. group Id
        OG001
        value
        2.2
    title
    Week 24 (IgG)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3.5
      2. group Id
        OG001
        value
        0
    title
    Week 40 (IgG)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4.3
      2. group Id
        OG001
        value
        0
    title
    Week 52 (IgG)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        7.6
      2. group Id
        OG001
        value
        11.9
    title
    Baseline (IgM)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        24.6
      2. group Id
        OG001
        value
        23.2
    title
    Week 16 (IgM)
denoms
  1. counts
    1. group Id
      OG000
      value
      67
    2. group Id
      OG001
      value
      68
    units
    Participants
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.
    id
    OG000
    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.
    id
    OG001
    title
    Mycophenolate Mofetil (MMF)
param Type
NUMBER
population Description
The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug.
reporting Status
POSTED
time Frame
Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018)
title
Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice