A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
4 years, 0 months, 11 days
Rheumatoid arthritis (RA) is a chronic inflammatory disease that leads to joint damage, deformity, and a high rate of disability and unemployment. There is a lack of effective treatment options for RA. RA is seen more in women than men, it costs the economy millions of pounds a year and it can shorten a patients lifespan by approximately 10 years.
Interstitial lung disease (ILD) is commonly seen in those patients with RA. ILD significantly contributes to increased mortality in patients with RA (a study has shown that patients with RA related ILD are at nearly 3 times the risk of premature death compared to patients without this complication).
Current treatment for RA has achieved a great improvement in the control of articular disease, however, unfortunately these benefits have not extended to rheumatoid arthritis associated lung disease (RA-ILD). Pirfenidone treatment is safe and well tolerated in idiopathic pulmonary fibrosis (IPF). RA-ILD shares many characteristics with IPF and therefore pirfenidone may be of benefit in RA-ILD. This study is designed to evaluate whether pirfenidone 2403 mg a day reduces the decline in a patients lung function or mortality over 52 weeks, compared with placebo, in patients with RA-ILD.
East Midlands - Leicester South Research Ethics Committee
Date of REC Opinion
15 Sep 2017
Further Information Favourable Opinion