Research

Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis

IRB Number: 13153

Institutional Review Board, Hospital for Special Surgery

March 28, 2014

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

Jessica K. Gordon, MD
Lindsay Lally, MD
Nina Paddu, BA
Daniele Lerner, BA
Uzunma Udeh, BA

Summary

The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo. This is a multicenter study. The target enrollment across all sites is 400. At this site, we expect to enroll 8-10 patients. The study will be approximately 3 years in length

Inclusion/Exclusion Criteria

Inclusion Criteria:

• Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria
• Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide
• Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment
• Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart
• Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission

Exclusion Criteria

• Pregnant or nursing
• Receipt of a B cell targeted therapy (other than rituximab) at anytime
• Receipt of an investigational biological agent within the past 60 days
• Required management of acute or chronic infections within the past 60 days
• Current drug or alcohol abuse or dependence
• Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• History of severe allergic reaction to contrast agents or biological medicines

Contact Information

Nina Paddu
paddun@hss.edu
212.774.7194



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