Interstitial Lung Disease

RA and Interstitial Lung Disease

Principal Investigator: Paul F. Dellaripa, MD

Study Contact: Maura Alvarez (617-732-8626; malvarezbaumgartner@bwh.harvard.edu)

Funding Agency: Genentech, Inc.

Study Summary: A randomized, double-blind, placebo-controlled, phase 2 study of safety, tolerability and efficacy of pirfenidone in patients with rheumatoid arthritis interstitial lung disease (Trail I): This is a 52-weeks (1 year) duration for patients with Rheumatoid Arthritis (RA) and ILD. Our objective is to assess the efficacy and safety of pirfenidone as compared to placebo in patients with RA-associated interstitial lung disease.

Patient Criteria: Participants ages 18 and over diagnosed with rheumatoid Arthritis (RA) and interstitial lung disease (ILD).

Visit Summary: Is a one-year study that consists in 9 visits that will occur at Brigham and Women’s Hospital Main Campus plus 3 phone calls. The visits will consist of a physical exam, questionnaires, and blood collection.

Patient Remuneration: Parking transportation vouchers will be provided.

SLS III

Principal Investigator: Paul F. Dellaripa, MD

Study Contact: Maura Alvarez (617-732-8626; malvarezbaumgartner@bwh.harvard.edu)

Funding Agency: Genentech, Inc.

Study Summary: Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease (SLS III). This is a 19-month duration study for patients with scleroderma-related interstitial lung disease. The drug dose is Mycophenolate Mofetil 1500mg and Pirfenidone 801 mg vs Mycophenolate Mofetil.

Patient Criteria: Patients older than 18 years of age with Scleroderma and Interstitial Lung Diease

Visit Summary: monthly blood draws for labs for the first 6 months, then every 3 months. For a total of 11 visits. The visits will consist of a physical exam, questionnaires, and blood.

Patient Remuneration: Parking transportation vouchers will be provided.

AttackMY-ILD

Principal Investigator: Paul F. Dellaripa, MD

Study Contact: Maura Alvarez (617-732-8626; malvarezbaumgartner@bwh.harvard.edu)

Funding Agency: Bristol Myers Squibb

Study Summary: Abatacept for the treatment of myositis-associated interstitial lung disease. A 24-week (6 months) placebo-controlled pilot study followed by a 24 -week open label extension phase. Our objective is to evaluate the efficacy, safety and tolerability of Abatacept and standard of care vs. standard of care in patients with Syn-ILD.

Patient Criteria: Participants ages 18 and over with anti-synthetase syndrome and interstitial lung disease (ILD) taking SOC immunosuppressive therapy.

Visit Summary: a total of 3 visits during a 24-week period followed by other 3 visits during a 24-week period with open label (during this period all the participants will receive the medication)

Patient Remuneration: $28.75 for each visit you complete.