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NCT00104299 · OUTCOME

The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis · Source last updated 2017-04-21

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

Measure
NUMBER
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
18 months post-randomization

What was measured

Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease

Analysis population: Intent-to-treat

Groups in this outcome

Rituximab

Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.

Control Group

Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.

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

Analysis denominator · Participants

GroupSource count
Rituximab99
Control Group98

Reported measurements

25% Quartile (95%CI)
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab243Not reported172NASome survival parameters are not estimable when there are small numbers of events
Control Group230Not reported145NASome survival parameters are not estimable when there are small numbers of events
50% Quartile (95%CI)
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RituximabNANot reportedNANASome survival parameters are not estimable when there are small numbers of events
Control GroupNANot reportedNANASome survival parameters are not estimable when there are small numbers of events
75% Quartile (95%CI)
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RituximabNANot reportedNANASome survival parameters are not estimable when there are small numbers of events
Control GroupNANot reportedNANASome survival parameters are not estimable when there are small numbers of events

Source statistical analyses

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

  1. ci Lower Limit
    0.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.7
    group Description
    Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.761
    p Value Comment
    The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission
    param Type
    Cox Proportional Hazard
    param Value
    0.9
    statistical Comment
    The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.7
    group Description
    Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.761
    p Value Comment
    The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission
    param Type
    Cox Proportional Hazard
    param Value
    0.9
    statistical Comment
    The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Some survival parameters are not estimable when there are small numbers of events
        group Id
        OG000
        lower Limit
        172
        upper Limit
        NA
        value
        243
      2. comment
        Some survival parameters are not estimable when there are small numbers of events
        group Id
        OG001
        lower Limit
        145
        upper Limit
        NA
        value
        230
    title
    25% Quartile (95%CI)
  2. categories
    1. measurements
      1. comment
        Some survival parameters are not estimable when there are small numbers of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Some survival parameters are not estimable when there are small numbers of events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    50% Quartile (95%CI)
  3. categories
    1. measurements
      1. comment
        Some survival parameters are not estimable when there are small numbers of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Some survival parameters are not estimable when there are small numbers of events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    75% Quartile (95%CI)
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      98
    units
    Participants
description
Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. \[1\] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
    id
    OG000
    title
    Rituximab
  2. description
    Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
    id
    OG001
    title
    Control Group
param Type
NUMBER
population Description
Intent-to-treat
reporting Status
POSTED
time Frame
18 months post-randomization
title
The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups
type
SECONDARY
unit Of Measure
Days

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Preserved source evidence · Not medical advice