MIRA
Research type
Research Study
Full title
Methotrexate use Improvement in Rheumatoid Arthritis using Biomarker Feedback (MIRA): A Feasibility Trial
IRAS ID
255407
Contact name
James Bluett
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 27 days
Research summary
Rheumatoid arthritis (RA) affects up to 1% of the adult population. It is a condition that is treatable by medications. Methotrexate (MTX) is the first-line therapy for RA however, up to 60% of patients prescribed MTX still have active RA. This puts these patients at higher risk of joint damage compared to those whose RA is under control.
One important explanation for the poor control in those who receive treatment is that patients, for many reasons, do not take their medications as recommended (non-adherence). Non-adherence is associated with increased costs to the NHS and reduced response to MTX.
Our study will assess whether it is achievable to conduct a much larger study to explore whether a review of how well patients are coping with MTX can improve RA control. Understanding the reasons for poor RA control has the potential to improve the health and well-being of individual patients, avoid unnecessary tests and hospital appointments and save money in healthcare.
We will recruit 50 patients with RA who have been prescribed MTX for more than 2 years. 25 patients will be asked to donate blood samples and complete questionnaires, but their treatment will continue as standard. The blood tests will measure patients MTX levels. The results of the test provide a direct confirmation of medication adherence. For the other 25 patients, the results of the blood tests will be fed back to them with tailored targeting of the main reason(s) for the deviation from the prescribed MTX. At the end of the study, we will assess the feasibility of a randomised controlled trial of a biochemical screening of adherence guided intervention in patients with RA treated with MTX.REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0047
Date of REC Opinion
25 Mar 2019
REC opinion
Further Information Favourable Opinion