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NCT00104299 · ClinicalTrials.gov registry record · Phase 2
Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 197
- Enrollment target
NCT00104299: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00104299 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 197 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00104299, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 197 participants
- Enrollment target
Study Summary
Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.
Primary Outcome
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.
Interventions
- DRUG Prednisone
- DRUG Azathioprine
- DRUG Rituximab plus cyclophosphamide placebo (rituximab group)
- DRUG Cyclophosphamide plus rituximab placebo (control group)
- DRUG Methylprednisolone (or other glucocorticoid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2005-01 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00104299 record still lists
NCT00104299 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 5 interventions - of which Prednisone is the first listed.
NCT00104299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00104299 about?
NCT00104299 is a clinical study titled "Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis". Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types ...
What is the current status of trial NCT00104299?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 197 participants. The study started on 2005-01. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00104299?
The interventions under investigation include: Prednisone (DRUG), Azathioprine (DRUG), Rituximab plus cyclophosphamide placebo (rituximab group) (DRUG), Cyclophosphamide plus rituximab placebo (control group) (DRUG), Methylprednisolone (or other glucocorticoid) (DRUG).
Who is sponsoring clinical trial NCT00104299?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00104299's enrollment target sits among peer trials
197 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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