TriangleNCT00104299 · OUTCOME
Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
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
Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0. \[1\] 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 | Source count |
|---|---|
| Rituximab | 99 |
| Control Group | 98 |
Reported measurements
25% Quartile (95%CI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 30 | Not reported | 29 | 34 | Not reported |
| Control Group | 29 | Not reported | NA | NA | Confidence limits not estimable due to no variability around quartile |
50% Quartile (95%CI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 57 | Not reported | 41 | 63 | Not reported |
| Control Group | 43 | Not reported | 30 | 58 | Not reported |
75% Quartile (95%CI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 119 | Not reported | 69 | 123 | Not reported |
| Control Group | 112 | Not reported | 61 | 120 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.3
- estimate Comment
- The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.497
- param Type
- Cox Proportional Hazard
- param Value
- 1.0
- statistical Comment
- The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.3
- estimate Comment
- The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.497
- param Type
- Cox Proportional Hazard
- param Value
- 1.0
- statistical Comment
- The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29
- upper Limit
- 34
- value
- 30
- comment
- Confidence limits not estimable due to no variability around quartile
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 29
- title
- 25% Quartile (95%CI)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 41
- upper Limit
- 63
- value
- 57
- group Id
- OG001
- lower Limit
- 30
- upper Limit
- 58
- value
- 43
- title
- 50% Quartile (95%CI)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 69
- upper Limit
- 123
- value
- 119
- group Id
- OG001
- lower Limit
- 61
- upper Limit
- 120
- value
- 112
- title
- 75% Quartile (95%CI)
- denoms
- counts
- group Id
- OG000
- value
- 99
- group Id
- OG001
- value
- 98
- units
- Participants
- description
- Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)\[1\] of 0. \[1\] 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
- 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
- Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups
- type
- SECONDARY
- unit Of Measure
- Days
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Preserved source evidence · Not medical advice