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NCT02383589 · OUTCOME

Time to Initial Sustained Complete Remission

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
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)

Analysis population: The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.

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)62
Mycophenolate Mofetil (MMF)63

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab (RTX)NANot reported32.1NAThe median is not estimable due to limited number of events
Mycophenolate Mofetil (MMF)NANot reportedNANAThe median is not estimable due to limited number of events

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.81
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0003
    p Value Comment
    P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization
    param Type
    Hazard Ratio (HR)
    param Value
    4.83
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    1.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.81
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0003
    p Value Comment
    P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization
    param Type
    Hazard Ratio (HR)
    param Value
    4.83
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median is not estimable due to limited number of events
        group Id
        OG000
        lower Limit
        32.1
        upper Limit
        NA
        value
        NA
      2. comment
        The median is not estimable due to limited number of events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      63
    units
    Participants
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
The mITT population included participants in the ITT population (all randomized participants who received any part of an infusion of study drug or oral administration of study drug), excluding the 10 TM participants. This population was used in the analyses of efficacy outcomes.
reporting Status
POSTED
time Frame
From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
title
Time to Initial Sustained Complete Remission
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice