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June 27, 2006

Rituximab Therapy For The Induction Of Remission And Tolerance In ANCA-Associated Vasculitis

IRB Number: 25010

Institutional Review Board
Hospital for Special Surgery


The safety of study participants is our top priority. The trial is approved and periodically reviewed by an 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.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Robert F. Spiera, MD

Co-Investigators

Stephen DiMartino, MD
Kyriakos A. Kirou, MD
Jonathan Samuels, MD

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:

  1. Age: They must be over 15 years of age.
  2. Weight: They must weigh at least 40 kg.
  3. Diagnosis type: They must be diagnosed with WG or MPA
  4. 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:

  1. Diagnosis: They are diagnosed with Churg Strauss syndrome
  2. Limited disease: They have limited disease that would not normally be treated with CYC.
  3. Severe disease: They require mechanical ventilation because of alveolar hemorrhage.
  4. 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

Stacey Kloiber, RN
212.774.7194





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