NCT00104299 · OUTCOME

The Duration of Remission (BVAS=0), 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 remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.

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

Group	Source count
Rituximab	99
Control Group	98

Reported measurements

25% Quartile (95%CI)

Values in Days · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Rituximab	246	Not reported	152	335	Not reported
Control Group	168	Not reported	141	300	Not reported

50% Quartile (95%CI)

Values in Days · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Rituximab	NA	Not reported	403	NA	Some survival parameters are not estimable when there are small numbers of events
Control Group	NA	Not reported	353	NA	Some survival parameters are not estimable when there are small numbers of events

75% Quartile (95%CI)

Values in Days · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Rituximab	NA	Not reported	NA	NA	Some survival parameters are not estimable when there are small numbers of events
Control Group	NA	Not reported	NA	NA	Some 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.

ci Lower Limit
0.6
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.5
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
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.861
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 remission
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.6
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.5
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
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.861
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 remission
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
152
upper Limit
335
value
246
group Id
OG001
lower Limit
141
upper Limit
300
value
168
title
25% Quartile (95%CI)
categories
measurements
comment
Some survival parameters are not estimable when there are small numbers of events
group Id
OG000
lower Limit
403
upper Limit
NA
value
NA
comment
Some survival parameters are not estimable when there are small numbers of events
group Id
OG001
lower Limit
353
upper Limit
NA
value
NA
title
50% Quartile (95%CI)
categories
measurements
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
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

counts
group Id
OG000
value
99
group Id
OG001
value
98
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
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 Remission (BVAS=0), 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