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Research

Abatacept (CTLA4-lg) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)

IRB Number: 2015-267

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. Speira, MD

Co-Investigators

Jessica Gordon, MD

Lindsay Lally, MD

Annel Fernandez

Emily Bakaj

Alexandra Morquette

Summary

This is a multi-center, randomized, double-blind, placebo-controlled trial whose purpose it is to determine whether abatacept (which is also called Orencia® or CTLA4-Ig) is effective in treatment of non-severe, releasing granulomatosis with polyangiitis (GPA).  Patients who enter the trial will be randomized to either abatacept or placebo and will be maintained on a stable dose of their maintenance immunosuppressive agent which may include methotrexate (MTX), azathioprine (AZA), mycophenolate (MA), or leflunomide (LEF), and will undergo a blinded randomization to receive abatacept or placebo. Patients will additionally receive prednisone 30 mg daily that will then be tapered to zero using a standardized tapering schedule. After the screening visits, patients will have follow up visits every 2-3 months for a total of 5 follow up visits as part of the one year randomized period. After the randomized period, patients may choose to continue and enter a one year open treatment period.  The  target number of patients to be enrolled is 5.

Inclusion/Exclusion Criteria

This is a multi-center, randomized, double-blind, placebo-controlled trial whose purpose it is to determine whether abatacept (which is also called Orencia® or CTLA4-Ig) is effective in treatment of non-severe, releasing granulomatosis with polyangiitis (GPA).  Patients who enter the trial will be randomized to either abatacept or placebo and will be maintained on a stable dose of their maintenance immunosuppressive agent which may include methotrexate (MTX), azathioprine (AZA), mycophenolate (MA), or leflunomide (LEF), and will undergo a blinded randomization to receive abatacept or placebo. Patients will additionally receive prednisone 30 mg daily that will then be tapered to zero using a standardized tapering schedule. After the screening visits, patients will have follow up visits every 2-3 months for a total of 5 follow up visits as part of the one year randomized period. After the randomized period, patients may choose to continue and enter a one year open treatment period.  The  target number of patients to be enrolled is 5.

Contact Information

Annel Fernandez
212.774.2123
fernandeza@hss.edu