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.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Jessica Gordon, MD
Lindsay Lally, MD
Annel Fernandez
Emily Bakaj
Alexandra Morquette
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.
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.
Annel Fernandez
212.774.2123
fernandeza@hss.edu