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Welcome to the LEADER Trial

Full study title: The clinical and cost effectiveness of oraL vErsus intrAmuscular glucocorticoiDs in rhEumatoid aRthritis.

What is the purpose of the study?
Rheumatoid arthritis (RA) causes joint pain and swelling which affects people’s day to day activities and quality of life.  Treatment for rheumatoid arthritis usually involves medicines called disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate. DMARDs help to stop rheumatoid arthritis from getting worse, however they can take up to six months to fully work. 
 

Whilst waiting for DMARDs to work, patients are offered treatment with steroids which act quickly to control the symptoms. These steroids can be given as an injection into the muscle “intra-muscular” or as daily tablets which need to be swallowed. Although steroids are good at controlling symptoms of RA, they should not be taken long term, and they can cause side-effects.
 

Doctors currently do not know whether it is better to give steroids for rheumatoid arthritis as an intra-muscular injection or as tablets and what dose (amount) of these steroids is best to use. The LEADER study is comparing different doses of steroids which may be given either as a one-off injection or tablets taken daily for either 4 or 6 weeks to see which is better at controlling the disease.
 

TAKING PART
Taking Part
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We are hoping to enrol up to 448 patients with rheumatoid arthritis from approximately 30 rheumatology outpatient sites in the UK. 

Please click the link below for a full list of recruiting Hospitals.

LEADER All Sites Page | LEADER (ox.ac.uk)

LATEST Updates
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04/07/2025

The LEADER study opened to recruitment!

STUDY ORGANISATION AND FUNDING

The trial is funded by the National Institute for Health and Care Research (NIHR), Health Technology Assessment (HTA) programme and is sponsored by the University of Manchester.

The Oxford Clinical Trials Research Unit will be managing the study.

This project has been developed in collaboration with patient partners.

Recruitment Progress:

1
0

Date of latest recruit:

No date given

Site of latest recruit:

No site given
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LEADER Trial

Botnar Research Centre
Windmill Road
Headington
Oxford
OX3 7LD

Chief Investigator

Dr James Bluett
University of Manchester

Approval References

REC Reference: 24/EM/0277

IRAS: 1010280

ISRCTN: 32090559

Contacts

Telephone: 0808 281 5345

Email: leader@ndorms.ox.ac.uk