Rheumatoid Arthritis-related Interstitial Lung Disease (RA-ILD) Trial

Landmark Study Evaluates Antifibrotic Therapy in Patients with Interstitial Lung Disease Associated with Rheumatoid Arthritis

Experts in the Lung Center at Brigham and Women’s Hospital (BWH) are leading a groundbreaking trial to assess the use of the antifibrotic therapy pirfenidone in patients with rheumatoid arthritis-related interstitial lung disease (RA-ILD). There are currently no effective treatments for progressive fibrotic lung disease in patients with rheumatoid arthritis.

International Study in RA-ILD

Dr. Rosas is the overall Principal Investigator of the first randomized clinical trial testing medication for pulmonary fibrosis in rheumatoid arthritis patients. This double-blinded study (Phase II Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease) is open to enrollment at Brigham and Women’s Hospital. Paul F. Dellaripa, MD, and Tracy J. Doyle, MD, are the site principal investigators. Overall, this study will enroll approximately 270 adult participants (ages 18 to 85) at 16 sites in the United States, 10 sites in the United Kingdom, and four sites in Canada. Patients will be randomized to receive either pirfenidone or placebo for 52 weeks. The primary outcome of the study is to assess the efficacy of pirfenidone in RA-ILD as defined by progression-free survival over the course of the study.

“Patients with rheumatoid arthritis-associated interstitial lung disease have clinical features that closely resemble idiopathic pulmonary fibrosis, so we anticipate that the results of previous trials can be quickly translated to the RA-ILD patient population,” said Dr. Dellaripa.

Eligible participants must meet 2010 ACR/EULAR criteria for RA, as well as ILD, determined by imaging as well as lung biopsy (when available). Participants also are required to have a percent predicted FVC > 40 and < 80 and percent predicted DLCO > 30 and < 80 at screening. The trial is inclusive of patients receiving stable doses of currently available treatments for RA.

“We expect that this trial will provide us with a tremendous amount of information about the natural history of RA-ILD and help us better understand this vastly understudied patient population,” said Dr. Doyle.

In addition, specialists in the Lung Center also are participating in a second study of antifibrotic agents for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) and other connective tissue diseases.

For more information regarding this trial or to inquire about enrolling eligible patients, please contact Dr. Rosas at (617) 732-7821 or irosas@partners.org.

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