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NCT00104299 · OUTCOME

Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization

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
participants
Interval / dispersion
Not reported
Time frame
6 months post-randomization

What was measured

The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control \[1\] 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: Safety Sample

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

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab62Not reportedNot reportedNot reportedNot reported
Control Group51Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -3.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95.1
    ci Upper Limit
    24.4
    group Description
    The p-value is from a chi-square test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.133
    param Type
    95.1% Confidence Interval of Difference
    param Value
    10.6
    statistical Comment
    At 6 months, the confidence interval is 95.1%.
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    -3.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95.1
    ci Upper Limit
    24.4
    group Description
    The p-value is from a chi-square test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.133
    param Type
    95.1% Confidence Interval of Difference
    param Value
    10.6
    statistical Comment
    At 6 months, the confidence interval is 95.1%.
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        51
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      98
    units
    Participants
description
The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control \[1\] 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
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
Safety Sample
reporting Status
POSTED
time Frame
6 months post-randomization
title
Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice