Rheumatoid arthritis Musculoskeletal Diseases
Conditions
Interventions
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
Sponsors
University of Manchester
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome as of 10/04/2026: DAS(CRP)-28 - disease activity at Baseline, Weeks 4, 12 Previous primary outcome: DAS(CRP)-28 - disease activity at Baseline, Weeks 2, 4, 8, 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 10/04/2026: 1. Disease activity is measured using EULAR Boolean remission and ACR20/50/70 at Baseline, Weeks 4, 12 and 24; and using DAS(CRP)-28 at Baseline, Weeks 2, 4, 8 and 12. 2. Patient-reported outcomes are measured using FACIT, VAS (pain), RA-QoL, WPAI, and HAQ-DI at Baseline, Weeks 4, 12, and 24; pain is measured weekly from Baseline to Week 24. 3. Analgesic use is measured by collecting patient’s analgesic usage at Baseline, Weeks 4, 12, and 24. 4. Toxicity is measured using an early morning cortisol suppression at Week 12; collecting a GTI (glucocorticoid toxicity index) at Baseline, Weeks 12 and 24; collecting adverse events of special interest (AESIs) at Weeks 12 and 24; and by assessing for skin changes at injection site (IM arms only) at Weeks 4, 12 and 24. 5. Cumulative dose is measured by two methods: first, by collecting data from patient’s medical notes on their GC dose prescribed, collected at Baseline, Weeks 4, 12, and 24; and secondly, by collecting data on patient’s GC adherence to treatment allocation, collected from (i) Oral Arm participants weekly from Baseline to Week 24 via participant-reported steroid diaries, and (ii) from IM Arm participants at Baseline, Weeks 4, 12 and 24 via participant’s medical notes. 6. Economic evaluation is measured using a healthcare resource utilisation questionnaire at Baseline, Weeks 4, 12, and 24; EQ-5D-5L at Baseline, Weeks 4, 12 and 24; and collecting Medication usage at Baseline, Weeks 4, 12 and 24. 7. Therapy acceptability to patients is measured using TFA at Weeks 12 and 24; BMQ-specific at Baseline, Weeks 12 and 24; and interviews and/or focus groups post-Week 24. 8. Barriers to recruitment are measured using 1:1 interviews with patients who decline participation. 9. Experience and views of healthcare professionals are measured using 1:1 interviews and/or focus groups from the start of recruitment to the end of the trial. Previous secondary outcomes: 1. Disease activit | — |
Countries
United Kingdom
Contacts
Public ContactAnne Francis
Outcome results
None listed