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TRAIL1

  • Research type

    Research Study

  • Full title

    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease

  • IRAS ID

    220334

  • Contact name

    Felix Woodhead

  • Contact email

    felix.woodhead@uhl-tr.nhs.uk

  • Sponsor organisation

    University Hospitals of Leicester NHS Trust

  • Eudract number

    2017-000149-30

  • Clinicaltrials.gov Identifier

    NCT02808871

  • Duration of Study in the UK

    4 years, 0 months, 11 days

  • Research summary

    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.

  • REC name

    East Midlands - Leicester South Research Ethics Committee

  • REC reference

    17/EM/0315

  • Date of REC Opinion

    15 Sep 2017

  • REC opinion

    Further Information Favourable Opinion