Comparison · NCT00104299-d74bd21a
Rituximab vs Control Group: Disease Remission
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Rituximab vs Control Group: Disease Remission. Trial comparisons, record NCT00104299-d74bd21a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00104299-d74bd21a
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.636 | 0.538 | 0.724 | wilson | |
| Risk in group 2 | 0.531 | 0.433 | 0.626 | wilson | |
| Risk difference, group 1 minus group 2 | 0.106 | -0.0314 | 0.238 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.945 | 1.52 | log | |
| Odds ratio, group 1 over group 2 | 1.55 | 0.875 | 2.74 | log | |
| Number needed to treat, for one more participant with the outcome on Rituximab than on Control Group | 9.46 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 63 | 99 | OG000 |
| Group 2 | 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. | 52 | 98 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Disease Remission
- 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.
- Time frame
- 6 months post-randomization
- Population
- Intent-to-treat (ITT) sample with worst case imputation
Source ClinicalTrials.gov
Trial
- Title
- Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
- NCT number
- NCT00104299
- Phases
- PHASE2, PHASE3
- Conditions
- Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis
- Interventions
- Rituximab plus cyclophosphamide placebo (rituximab group), Cyclophosphamide plus rituximab placebo (control group), Azathioprine, Methylprednisolone (or other glucocorticoid), Prednisone
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2011-08-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00104299?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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