Comparing a one-time intramuscular steroid shot versus a short oral steroid course for RA flares
Official title: STeroid Options for RA Management (STORM-RA): Oral Versus Intramuscular Steroid Use to Control Rheumatoid Arthritis Flares: A Pragmatic Randomized Clinical Trial
Run by Sunnybrook Health Sciences Centre · NCT07245732 · Data updated 2026-11-12
This tests whether a single intramuscular steroid injection or a short course of oral steroid pills gives better symptom relief for people with rheumatoid arthritis who are experiencing a flare.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 5 sites (Toronto, Ontario and 4 other locations) |
| Status | Recruiting |
| Started | April 2026 |
| Main results expected | March 2029 |
| Study ends | July 2029 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07245732 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a rheumatologist-confirmed diagnosis of rheumatoid arthritis who are experiencing a flare, are on stable csDMARD/tsDMARD/bDMARD therapy for at least 8 weeks, and have not received systemic or intra-articular glucocorticoids in the prior 4 weeks.
✕Probably not a fit
Patients with contraindications to systemic glucocorticoids or intramuscular injections, active malignancy, pregnancy or breastfeeding, or recent steroid use are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pragmatic, phase 4 interventional study randomizes people with rheumatologist-verified RA who are having a flare to receive either a single intramuscular glucocorticoid injection or a short tapering course of oral glucocorticoids. The trial emphasizes patient-reported outcomes such as pain, function, fatigue, and treatment satisfaction, alongside safety and short-term disease activity measures. It includes a qualitative component and a study-within-a-trial (SWAT) to capture patient experience and implementation issues. Participants must be on stable background DMARD therapy and without recent systemic or intra-articular steroid exposure.
Why it matters
Potential benefit: If successful, the study could identify the faster or more acceptable steroid approach for easing flare symptoms and improving day-to-day function and satisfaction.
How similar studies have gone: Both oral taper regimens and single intramuscular steroid injections are used in practice and have evidence for reducing inflammation, but there is little direct head-to-head evidence focused on patient-reported symptom relief and experience.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rheumatologist verified RA diagnosis. * Patients are allowed to be on non-steroidal anti-inflammatory drugs (NSAIDs) prior to randomization, but the dosages must be stable for ≥2 weeks prior to randomization. * Patients must be on stable doses of conventional synthetic disease-modifying antirheumatic drugs (csDMARD)/targeted synthetic disease-modifying antirheumatic drugs (tsDMARD)/biologics (bDMARDs) for ≥8 weeks prior to randomization. Exclusion Criteria: * Allergies, intolerances or contraindications to systemic GCs or IM injections * Patients with active malignancy, are pregnant or breastfeeding. * Patients who have received systemic or intra-articular GC within 4-weeks of randomization.
Where it's running
-
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting -
St. Michael's Hospital
Toronto, Ontario, Canada Recruiting -
Women's College Hospital
Toronto, Ontario, Canada Recruiting -
Toronto Western Hospital
Toronto, Ontario, Canada Recruiting -
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Timothy S.H. Kwok, MD, MSc, FRCPC
- Email: timothysh.kwok@utoronto.ca
- Phone: 416-480-4580
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.