Unknown Digestion, Kidneys & Other Organs NIHR-supported project Bones, Joints & Muscles

The clinical and cost effectiveness of oraL vErsus intrAmuscular glucocorticoiDs in rhEumatoid aRthritis (LEADER)

In plain English

AI plain-English summary

A clinical trial is directly comparing daily steroid tablets against intramuscular injections to find which works better—and causes fewer side effects—for people with active rheumatoid arthritis who are starting or changing their usual medication. This matters because glucocorticoids are widely used as a short-term “bridge” to control inflammation while slower-acting disease-modifying drugs take effect, but doctors lack clear evidence on whether tablets or injections are more effective, safer, and more acceptable to patients. Both routes have different risks: tablets are convenient but require daily adherence and may cause cumulative toxicity; injections deliver a single dose but require a clinic visit and can cause injection-site reactions. If the trial shows one route is clearly superior, it could change standard NHS practice for thousands of patients each year. A clear winner would allow clinicians to prescribe the most effective and least toxic option from the start, reducing unnecessary side effects and improving disease control during a critical treatment transition. The embedded economic evaluation will also tell the NHS whether the better option is cost-effective, helping to guide routine prescribing decisions.

View original technical description
The aim of the trial is to identify the most effective and safest way of using glucocorticoids in patients with active rheumatoid arthritis who are initiating, switching or escalating an anti-rheumatic medicine, whilst limiting toxicity and being acceptable to patients. The trial will assess whether an intramuscular injection or daily tablet is better at controlling the disease. Primary Objective: To compare the mean DAS(CRP)-28 over 12 weeks in participants commencing IM or oral short-term bridging glucocorticoid therapy who are initiating, escalating or switching DMARD therapy. Secondary Objectives: Include analyses to compare the effects of high vs. low GC dosing regimens on mean DAS(CRP)-28 separately between PO arms and IM arms; and to compare the effects of oral and IM GC on patient reported outcome measures, analgesic use, toxicity, and cumulative GC dose. Additional economic evaluation and qualitative studies via interviews and questionnaires will be conducted.

Researchers

Madhura Castelino (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

The clinical and cost effectiveness of oraL vErsus intrAmuscular glucocorticoiDs in rhEumatoid aRthritis: LEADER A Randomised Controlled Trial
The clinical and cost effectiveness of oraL vErsus intrAmuscular glucocorticoiDs in rhEumatoid aRthritis
Steroid-Reducing Options for ReLapsING PMR (STERLING-PMR): a pragmatic, randomised trial to compare the clinical and cost-effectiveness of adding immunosuppression to steroid-tapering treatment for patients with relapsing PMR, versus steroid-tapering alone
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Original classification

Infection, Immunopathology & Immunotherapeutics

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.