This phase 2 trial will evaluate the safety and effectiveness of pirfenidone (Esbriet) for the treatment of interstitial lung disease in patients with rheumatoid arthritis. The main outcome to be investigated is the level of lung disease progression.
The details
Although rheumatoid arthritis (RA) primarily affects the joints, other organs can become affected over time. Interstitial lung disease (ILD) is caused by over-activation of the immune system in RA. In ILD, lung tissue becomes scarred and patients may find it difficult to breathe. Pirfenidone is a drug that has multiple effects – it is anti-inflammatory and anti-fibrotic (scarring).
This phase 2 trial will evaluate the safety and effectiveness of pirfenidone for the treatment of RA-associated interstitial lung disease. The main outcome to be investigated is the level of lung disease progression.
Who are they looking for?
This trial will recruit 270 patients with RA-associated ILD. Patients must be on a stable dose of medication to treat RA. Each patient must also satisfy a number of criteria on the features of their ILD including at least 6 months since first diagnosis.
Patients cannot take part in the trial if they have smoked tobacco in the last 3 months or have been exposed to environmental conditions that may cause pulmonary fibrosis e.g. asbestos exposure. Other exclusion criteria include: history of other lung diseases, cancer, unstable cardiovascular disease, active infection, end-stage renal disease and pregnancy/breast-feeding, history of alcohol or substance abuse.
How will it work
Patients will be randomly assigned to one of two groups. One will receive pirfenidone three times daily and the other group will receive a placebo (substance with no active effect). Treatment will continue for 52 weeks. ILD will be assessed at the end of the study (52 weeks). Forced vital capacity (FVC, the amount of air that can be forcibly exhaled after a deep breath) will be measured.
The main outcome to be investigated is the level of lung disease progression as measured by FVC.
