The clinical and cost effectiveness of oraL vErsus intrAmuscular glucocorticoiDs in rhEumatoid aRthritis
Rheumatoid arthritis
Current interventions as of 10/04/2026: Arm A (PO30): Oral glucocorticoid (prednisolone) tablets. Starting dose of 30 mg once daily tapered down after each week over 5 weeks to 5 mg once daily. Total treatment duration is 6 weeks. Arm B (PO15): Oral glucocorticoid (prednisolone) tablets. Starting dose of 15 mg once daily tapered down after each week over 3 weeks to 5 mg once daily. Total treatment duration is 4 weeks. Arm C (IM120): One-off 120 mg intramuscular glucocorticoid injection (methylprednisolone). Treatment duration is 1 day. Arm D (IM80): One-off 80 mg intramuscular glucocorticoid injection (methylprednisolone). Treatment duration is 1 day. Each participant will be followed up for 24 weeks from randomisation, with in-person appointments at Baseline, Weeks 4, 12 and 24. The follow-up schedule is the same across all four trial arms. The participant randomisation process will be completed online using a randomisation tool embedded within the trial database. Previous interventions: Arm A (PO30): Oral glucocorticoid (prednisolone) tablets. Starting dose of 30 mg once daily tapered down after each week over 5 weeks to 5 mg once daily. Total treatment duration is 6 weeks. Arm B (PO15): Oral glucocorticoid (prednisolone) tablets. Starting dose of 15 mg once daily tapered down after each week over 3 weeks to 5 mg once daily. Total treatment duration is 4 weeks. Arm C (IM120): One-off 120 mg intramuscular glucocorticoid injection (methylprednisolone). Treatment duration is 1 day. Arm D (IM80): One-off 80 mg intramuscular glucocorticoid injection (methylprednisolone). Treatment duration is 1 day. Each participant will be followed up for 24 weeks from randomisation, with in-person appointments at Weeks 2, 4, 8, 12 and 24. The follow-up schedule is the same across all four trial arms. The participant randomisation process will be completed online using a randomisation tool embedded within the trial database.
Current inclusion criteria as of 10/04/2026: 1. Aged 18 years or over 2. Diagnosed with rheumatoid arthritis 3. Active disease defined as ≥3 tender and ≥3 swollen joints 4. Planning on initiating/switching to/escalating to one conventional synthetic (cs), biologic (b) or targeted synthetic (ts) DMARD 5. Willing and able to accept either trial arm allocation 6. Willing and able to give informed consent Previous inclusion criteria: 1. Aged 18 years or over 2. Diagnosed with rheumatoid arthritis that either currently or historically fulfils 2010 ACR/EULAR RA classification criteria 3. Active disease defined as ≥3 tender and ≥3 swollen joints 4. Planning on initiating/switching to/escalating to a conventional synthetic (cs), biologic (b) or targeted synthetic (ts) DMARD 5. Willing and able to accept either trial arm allocation 6. Willing and able to give informed consent
Current exclusion criteria as of 10/04/2026: 1. Oral, intramuscular or intra-articular glucocorticoid therapy within the past 28 days 2. Glucocorticoid therapy contraindicated (as determined by treating clinician) 3. Diagnosed within the last 6 months with fibromyalgia or chronic widespread pain 4. Known to be pregnant or female patient trying to conceive 5. Unstable or uncontrolled diabetes 6. Participating or planning to participate in another interventional clinical study/trial during the study period that in the opinion of the Investigator could affect LEADER outcomes 7. Any other severe concomitant disease that, in the opinion of the investigator, might interfere with trial procedures and/or assessments Previous exclusion criteria: 1. Oral, intramuscular or intra-articular glucocorticoid therapy within the past 3 months 2. Glucocorticoid therapy contraindicated (as determined by treating clinician) 3. Diagnosed within the last 6 months with fibromyalgia or chronic widespread pain 4. Known to be pregnant or female patient trying to conceive 5. Unstable or uncontrolled diabetes 6. Participating or planning to participate in another interventional clinical study/trial during the study period that in the opinion of the Investigator could affect LEADER outcomes 7. Any other severe concomitant disease that, in the opinion of the investigator, might interfere with trial procedures and/or assessments