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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Claire
Davies
+44 (0)113 3430281
Sterling@leeds.ac.uk
Dr
Sarah
Mackie
+44 (0)113 3938336
s.l.mackie@leeds.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Polymyalgia rheumatica (PMR)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Polymyalgia rheumatica (PMR) is an inflammatory disease affecting older people that causes pain and stiffness in the muscles in the shoulders, neck, hips and thighs. 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. However, 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 the same long-term toxicity that steroids do. The aim of this study is to find out whether there is an added benefit of DMARDs in relapsing PMR.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Contraindication to tapering steroid dose, or to methotrexate therapy2. Women who are currently pregnant or lactating or planning to become pregnant in the next 2 years3. Women of child-bearing potential (WCBP) or men unwilling to use an effective birth control measure (Appendix 2) whilst receiving treatment (either methotrexate or leflunomide) and for an appropriate period after the last dose of protocol treatment (6 months in the case of methotrexate, applicable for both male participants and women of childbearing potential [WCBP]). In the case of male participants the contraceptive measures can be taken by either themselves or their female partners4. A medical condition other than PMR that has required >2 courses of systemic glucocorticoid treatment lasting 5 days or more, or any course lasting 30 days or more, during the year prior to randomization5. Giant cell arteritis (previous or current)6. Rheumatoid arthritis, psoriatic arthritis or spondyloarthritis (previous or current)7. At the baseline visit active infection of sufficient severity to be a contra-indication to commencing methotrexate8. Treatment with trimethoprim or trimethoprim-sulfamethoxazole (co-trimoxazole) at the time of the baseline assessments9. Active gastric ulcer at the baseline visit10. Known prior history of a significant immunodeficiency syndrome, defined as an immunodeficiency severe enough to cause recurrent infections of sufficient frequency or severity to preclude DMARD treatment11. Known prior history of hereditary galactose intolerance, hereditary total lactase deficiency or hereditary disorder of glucose-galactose malabsorption12. Other medical condition that is severe enough to seriously compromise evaluation of the primary or key secondary endpoints13. Treatment with any immunosuppressive therapy (conventional synthetic, targeted synthetic or biological DMARD) within 3 months prior to randomisation14. Treatment with any investigational drug in the last 4 months prior to the start of protocol treatment15. Unable to complete essential study procedures and communicate with study staff independently16. Participants must NOT fulfil any of the following within 6 weeks prior to baseline: Haemoglobin <10.0 g/dL; total white cell count <3.5 x 10e9/L; absolute neutrophil count <1.5 x 10e9/L; platelet count <100 x 10e9; ALT (alanine aminotransferase) or AST >2 x upper limit of reference range for the laboratory conducting the test, eGFR (estimated glomerular filtration rate) <30 ml/min17. Evidence of respiratory disease on chest radiograph (performed during screening or within the 6 months prior to screening) of sufficient severity to be a contra-indication to commencing methotrexate Footnote 2: Contraindication to MTX includes comorbidities such as severe respiratory disease or chronic infections.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Claire
Davies
+44 (0)113 3430281
Sterling@leeds.ac.uk
Dr
Sarah
Mackie
+44 (0)113 3938336
s.l.mackie@leeds.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Leeds; University of Adelaide and funded by Health Technology Assessment Programme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 57926
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
