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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00104299
The ClinicalTrials.gov registry entry for NCT00104299 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 197 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Prednisone is the first listed.
NCT00104299 reports 0 study locations.
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.
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