TriangleNCT00104299 · OUTCOME
Disease Remission
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
A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.
Analysis population: Intent-to-treat (ITT) sample with worst case imputation
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 | Source count |
|---|---|
| Rituximab | 99 |
| Control Group | 98 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 63 | Not reported | Not reported | Not reported | Not reported |
| Control Group | 52 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -3.2
- ci Pct Value
- 95.1
- ci Upper Limit
- 24.3
- group Description
- In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- non-inferiority margin of -20%
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- p Value Comment
- P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O'Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.
- param Type
- Difference between group success rates
- param Value
- 10.6
- statistical Comment
- Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.
- statistical Method
- 95.1% CI of difference
Complete source fields
- analyses
- ci Lower Limit
- -3.2
- ci Pct Value
- 95.1
- ci Upper Limit
- 24.3
- group Description
- In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- non-inferiority margin of -20%
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- p Value
- <0.001
- p Value Comment
- P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O'Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.
- param Type
- Difference between group success rates
- param Value
- 10.6
- statistical Comment
- Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.
- statistical Method
- 95.1% CI of difference
- classes
- categories
- measurements
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 52
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 98
- units
- Participants
- description
- A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.
- 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 (ITT) sample with worst case imputation
- reporting Status
- POSTED
- time Frame
- 6 months post-randomization
- title
- Disease Remission
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice