STERLING-PMR
Research type
Research Study
Full title
Steroid-Reducing Options for ReLapsING PMR (The STERLING-PMR study): a multi-centre, Phase III, parallel-group, open-label, randomised controlled trial to compare the clinical and cost-effectiveness of adding immunosuppression to steroid-tapering treatment for patients with relapsing PMR, versus steroid-tapering alone
IRAS ID
1005826
Contact name
Emma Armstrong
Contact email
Sponsor organisation
University of Leeds
Eudract number
2023-000130-15
Research summary
Polymyalgia rheumatica (PMR) is an inflammatory disease affecting older people. It is treated with (cortico)steroid medication. As the steroid dose reduces, symptoms may return or worsen (relapse), needing an increase in dose. Steroid treatment often lasts over 2 years; long-term steroids have serious health risks and the best indicator of these risks is the total (cumulative) steroid dose given throughout the illness. Some patients are referred to rheumatology; these patients are often prescribed additional medications called DMARDs (such as methotrexate (MTX) or leflunomide (LEF)), which help control inflammation and reduce the need for steroids. But only 6% of NHS patients are given MTX, and even fewer are given LEF. With regular blood monitoring, DMARDs are very safe and do not have same long-term toxicity that steroids do. However, we do not know what is the added benefit of DMARDs in relapsing PMR.
We will recruit 200 people with PMR who have relapsed at least once in the past. All patients in the trial will continue gradual steroid reduction, guided by their GP. 100 of them, chosen at random, will also start MTX (this can be switched to LEF if there are side-effects from MTX).
We will follow up patients for 18 months. Every month, we will ask participants to record their current steroid dose using a questionnaire. Every 3 months we'll ask them to complete extra questionnaires about their health and their use of healthcare services. We will calculate the total amount of steroid taken over 18 months and compare the group allocated to DMARD to the group not allocated to DMARD. We will also test whether adding DMARD controls PMR better and improves the chances of stopping steroids. Health economic analysis will help us understand whether everything involved in prescribing DMARD for relapsing PMR would be a cost-effective and viable approach for the NHS.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0123
Date of REC Opinion
4 Oct 2023
REC opinion
Further Information Favourable Opinion