TMA medical advisor Dr. Rohit Aggarwal and Dr. Chester Oddis are recruiting patients with active interstitial lung disease (ILD) and antisynthetase antibody (Jo-1, PL-7, PL-12, EJ, OJ, KS), for a myositis clinical trial. Patients do not need to have active myositis symptoms. The trial is to test the effect of adding abatacept to standard-of-care immunosuppressive therapy.
Abatacept is a biologic agent that is already FDA-approved for rheumatoid arthritis. Because there is evidence that activated T-cells play a role in myositis-associated ILD, researchers want to test its effect in this new disease indication.
The multi-center, double-blind, placebo-controlled study will enroll 20 patients to receive weekly subcutaneous injections of either the treatment or placebo over the six-month trial. Patients will continue their standard-of-care immunosuppressive therapy throughout the trial. Patients may opt to participate in a six-week, open-label extension, in which all patients will receive the treatment. The study entails five to six in-person visits at the study site.
Study sites include Cedars-Sinai Medical Center in California, University of Colorado Anschutz Medical Center in Denver, Johns Hopkins Medical Center in Baltimore, Brigham & Women’s Hospital in Boston, and the University of Pittsburgh.
More information, including study sites and inclusion criteria, is available here.
Please contact study coordinator Courtney Ward at 412-648-9989 or email@example.com.