TriangleNCT00104299 · OUTCOME
Time to Complete Remission (BVAS=0, Off Glucocorticoids) 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 and completing taper of glucocorticoid by 6 months post-randomization. \[1\] 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 | 176 | Not reported | 173 | 177 | Not reported |
| Control Group | 177 | Not reported | 175 | 178 | Not reported |
50% Quartile (95%CI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 180 | Not reported | 178 | 182 | Not reported |
| Control Group | 183 | Not reported | 180 | 187 | Not reported |
75% Quartile (95%CI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab | 189 | Not reported | 183 | 253 | Not reported |
| Control Group | 266 | Not reported | 190 | 287 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.8
- 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
- 0.147
- param Type
- Cox Proportional Hazard
- param Value
- 1.3
- statistical Comment
- The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.9
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.8
- 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
- 0.147
- param Type
- Cox Proportional Hazard
- param Value
- 1.3
- statistical Comment
- The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 173
- upper Limit
- 177
- value
- 176
- group Id
- OG001
- lower Limit
- 175
- upper Limit
- 178
- value
- 177
- title
- 25% Quartile (95%CI)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 178
- upper Limit
- 182
- value
- 180
- group Id
- OG001
- lower Limit
- 180
- upper Limit
- 187
- value
- 183
- title
- 50% Quartile (95%CI)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 183
- upper Limit
- 253
- value
- 189
- group Id
- OG001
- lower Limit
- 190
- upper Limit
- 287
- value
- 266
- 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 and completing taper of glucocorticoid by 6 months post-randomization. \[1\] 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 Complete Remission (BVAS=0, Off Glucocorticoids) 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