Rituximab Therapy For The Induction Of Remission And Tolerance In ANCA-Associated Vasculitis
IRB Number: 25010
inactiveJune 27, 2006
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
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Principal Investigator
Co-Investigators
- Stephen DiMartino, MD
- Jessica K. Gordon, MD
- Uzunma Udeh, BA
Summary
200 participants nationwide 30 months
Study Duration: The common closing date will be 18 months after the last participant is enrolled.
Primary Objective: determine the efficacy of Rituximab (four weekly infusions) and glucocorticoids in the induction of remission of WG
Inclusion/Exclusion Criteria
Inclusion Criteria
Potential participants must meet all of the following:
- Age: They must be over 15 years of age.
- Weight: They must weigh at least 40 kg.
- Diagnosis type: They must be diagnosed with WG or MPA
- Screening diagnosis: They must be newly diagnosed patients, or they must have a disease flare
Exclusion Criteria
Potential participants with any of the following will NOT be enrolled in this study:
- Diagnosis: They are diagnosed with Churg Strauss syndrome
- Limited disease: They have limited disease that would not normally be treated with CYC.
- Severe disease: They require mechanical ventilation because of alveolar hemorrhage.
- Infection (systemic): They have an active systemic infection, active hepatitis B or active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
Contact Information
Uzunma Udeh, BA
212.774.2123
udehu@hss.edu