Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
Public ClinicalTrials.gov record NCT00104299. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00104299
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 197 participants
Conditions and interventions
Interventions
- Rituximab plus cyclophosphamide placebo (rituximab group) Drug
- Cyclophosphamide plus rituximab placebo (control group) Drug
- Azathioprine Drug
- Methylprednisolone (or other glucocorticoid) Drug
- Prednisone Drug
Drug
Eligibility (public fields only)
- Age range
- 15 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2005 (Type not available)
- Primary completion
- Dec 2008 (Actual)
- Completion
- Jan 2010 (Actual)
- Last update posted
- Apr 21, 2017
2005 – 2010
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| Johns Hopkins University | Baltimore | Maryland | 21224 | — |
| Boston University | Boston | Massachusetts | 02118 | — |
| Mayo Clinic Foundation | Rochester | Minnesota | 55905 | — |
| Hospital for Special Surgery | New York | New York | 10128 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00104299, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2017 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00104299 live on ClinicalTrials.gov.