Status:
COMPLETED
Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Genentech, Inc.
Conditions:
Vasculitis
Wegener's Granulomatosis
Eligibility:
All Genders
15+ years
Phase:
PHASE2
PHASE3
Brief 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 (W...
Detailed Description
Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality...
Eligibility Criteria
Inclusion
- Weight of at least 88 pounds(40 kilograms)
- Diagnosis of Wegener's granulomatosis or microscopic polyangiitis according to the definitions of the Chapel Hill Consensus Conference
- Newly diagnosed patient of Wegener's granulomatosis or microscopic polyangiitis OR must be experiencing a disease flare characterized by: (a) active disease with a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (BVAS/WG) of 3 or greater that would normally require treatment with CYC; OR (b) disease severe enough to require treatment with CYC; OR (c) must be positive for either PR3-ANCA (ANCA directed against proteinase 3) or MPO-ANCA (ANCA directed against myeloperoxidase)at the screening
- Willing to use acceptable forms of contraception for the duration of the study and for up to 1 year after stopping study medications
- Willing to report pregnancies (female participants or male participants' partners) occurring at any time during the study and for up to 1 year after stopping study medications
- Parent or guardian willing to provide informed consent, if applicable
Exclusion
- Diagnosis of Churg-Strauss Syndrome according to the definitions of the Chapel Hill Consensus Conference
- Have limited disease that would not normally be treated with CYC
- Requires mechanical ventilation because of alveolar hemorrhage
- History of severe allergic reactions to human or chimeric monoclonal antibodies
- Active systemic infection
- Have a deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia complicated by pleural cavity or lung abscess, within 6 months prior to study entry
- History of or current hepatitis B or C infection
- HIV (human immunodeficiency virus) infected
- Acute or chronic liver disease that, in the opinion of the investigator, may interfere with the study
- History of or active cancer diagnosed within the last 5 years. Individuals with squamous cell or basal cell carcinomas of the skin and individuals with cervical carcinoma in situ who have received curative surgical treatment may be eligible for this study.
- History of anti-glomerular basement membrane (anti-GBM) disease
- Other uncontrolled disease, including drug and alcohol abuse, that may interfere with the study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00104299
Start Date
January 1 2005
End Date
January 1 2010
Last Update
April 21 2017
Active Locations (8)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Johns Hopkins University
Baltimore, Maryland, United States, 21224
3
Boston University
Boston, Massachusetts, United States, 02118
4
Mayo Clinic Foundation
Rochester, Minnesota, United States, 55905