LEADER Trial: Oral Versus Intramuscular Glucocorticoids In Rheumatoid Arthritis

10 Jul 20265 min read0 viewsJournal Feed

GIST (Key Takeaways)

Introduction Glucocorticoid (GC) bridging therapy is recommended in patients with rheumatoid arthritis commencing a disease-modifying anti-rheumatic drug (DMARD). It is not clear whether GC therapy is better administered intramuscularly or orally and at what dose level.
The aim of the LEADER trial is to identify the most effective and safest way of using steroids in patients with uncontrolled RA who are starting a DMARD. Methods and analysis A multicentre, randomised, open-label, four-arm, parallel-group clinical trial with an internal pilot phase, economic evaluation and qualitative study of acceptability.
Participants will be randomised to one of four arms: arm A, 30 mg oral prednisolone tapering over 6 weeks; arm B, 15 mg oral prednisolone tapering over 4 weeks; arm C, Intramuscularly 120 mg methylprednisolone; and arm D, Intramuscularly 80 mg methylprednisolone. Participants will be assessed at baseline (pre-GC intervention), 4, 12 and 24 weeks.
The primary outcome measure is the mean DAS(CRP) - 28 over 12 weeks.

Clinical Editorial

BMJ Open published a clinical update in Research Highlights on 10 Jul 2026.

The item focuses on Clinical and cost-effectiveness of oral versus intramuscular glucocorticoids in rheumatoid arthritis: protocol for a multicentre randomised controlled trial with economic evaluation and qualitative sub-study (LEADER trial).

Review the original article for the full source wording and details.