Oral versus intramuscular glucocorticoids in rheumatoid arthritis
Research type
Research Study
Full title
The clinical and cost effectiveness of oraL vErsus intrAmuscular glucocorticoiDs in rhEumatoid aRthritis
IRAS ID
1010280
Contact name
James Bluett
Contact email
Sponsor organisation
The University of Manchester
ISRCTN Number
ISRCTN32090559
Research summary
Rheumatoid Arthritis (RA) causes joint pain and swelling affecting people’s daily activities and quality of life. The National Institute for Health and Care Excellence advise treatment with drugs called anti-rheumatic medicines, but they can take up to 6 months to work. Whilst waiting for these medicines to take effect, patients are offered another type of drug, steroids, which act quickly to control symptoms. Unfortunately, steroids have long-term side effects such as diabetes, weight gain and skin changes, so should only be used for short periods of time.
Steroids can be given as an injection into the muscle or as a daily tablet. Doctors currently do not know whether it matters which of these and what dose has the best balance between side effects and rapid symptom relief.
The LEADER trial aims to find the most effective and safest way of using steroids for patients with uncontrolled RA who are starting a new anti-rheumatic medicine. The trial will compare 4 different doses/ways of taking steroids: 1) higher dose steroid tablets that reduce in dose over six weeks, 2) lower dose steroid tablets that reduce in dose over four weeks, 3) a one-off higher dose steroid injection or 4) a one-off lower dose steroid injection.
Participants will be assessed regularly during the first 3 months and at 6 months to see how the treatment has affected their symptoms. The trial will compare how active the RA is, between tablets and injection and also dose levels, to find out which treatment is most effective.
The trial will also look at what impact the different doses and ways of taking steroids have on fatigue, ability to do day-to-day activities and work, quality of life, the amount of pain killers used and value for money to the NHS. Side effects such as weight gain and mood changes will be assessed and an at-home finger-prick blood sample will test if the steroid has affected the ability to produce a key hormone that controls the body’s stress response and blood pressure.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0277
Date of REC Opinion
3 Feb 2025
REC opinion
Further Information Favourable Opinion