What is the LEADER study?
The LEADER study is trying to find out the best way of using steroids which are routinely used to treat the symptoms of rheumatoid arthritis (RA). Doctors are wanting to find out what is the best way for individuals with RA to receive these steroids– either as a one-off injection into a muscle, which is called “intra-muscular” or as tablets which need to be swallowed daily for either 4 or 6 weeks to see which is better for controlling the symptoms of rheumatoid arthritis. The study will also compare different doses (amounts) of the steroids.
Please watch our brief animated video for an introduction to the LEADER study
Target Population
The LEADER trial will recruit adults aged 18 years and over with active RA planning on initiating/escalating/switching DMARD therapy.
Description of trial arms
LEADER is a randomised study, which means that the way and amount of steroid treatment a patient receives is randomly chosen by a computer. Those who agree to take part will be given at random one of the following four steroid treatments:
- Higher dose steroid tablets
- Lower dose steroid tablets
- Higher dose steroid injection
- Lower dose steroid injection
Planned Sample Size
448 participants (112 participants in each of the 4 trial arms)
No. of Research Sites
Approximately 30 (rheumatology outpatient clinics)
If you have any questions about the LEADER trial, please contact the Leader study team at the University of Oxford via the following email address: leader@ndorms.ox.ac.uk
You can also reach the Oxford Clinical Trials Research Unit on the following number: 0808 281 5345
