APRIL
Research type
Research Study
Full title
Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study
IRAS ID
184072
Contact name
Frances Hall
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2016-002569-68
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Early initiation of treatment for Rheumatoid arthritis (RA) can prevent several of the long term problems associated with the condition. However, many RA patients develop lung inflammation and scarring, called ‘interstitial lung disease’ (RA-ILD), contributing to early death for approximately 1 in 5 people. There is no proven treatment for these patients and some medications for RA can in fact worsen their lung disease. Therefore there is an urgent need to find safe medications that can not only control RA joint disease, but also prevent progression of RA-ILD. Abatacept is an approved drug for treating RA and is used widely. It is a newer RA medication, with a unique mechanism of action, and it has been shown to prevent progression of joint damage and improve physical function. We aim to assess the safety of this medication in patients with RA-ILD and improve our understanding of the mechanism of lung damage in rheumatoid disease.
We will perform a small clinical trial to assess the feasibility of performing a larger randomised controlled trial. A maximum of 30 patients with RA-ILD will be treated with abatacept infusions fortnightly for the first month, then every 4 weeks for a total of 20 weeks. In order to be eligible for the study, a patient must be able to provide written informed consent, be aged ≥18 years, meet a diagnosis of RA by 2010 EULAR/ACR criteria and have interstitial lung disease that has not responded to or progressed over 6 months despite conventional immunosuppression. Change in lung function (forced vital capacity) at 24 weeks will be evaluated.
To assess the mechanisms that may be involved with the development of ILD, we will assess the effects of abatacept on biomarkers obtained from the blood and the lung (bronchoalveolar lavage), including markers of infection (the lung microbiome).REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0621
Date of REC Opinion
4 May 2018
REC opinion
Further Information Favourable Opinion