Comparing a one-time intramuscular steroid shot versus a short oral steroid course for RA flares
STeroid Options for RA Management (STORM-RA): Oral Versus Intramuscular Steroid Use to Control Rheumatoid Arthritis Flares: A Pragmatic Randomized Clinical Trial
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 |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 5 sites (Toronto, Ontario and 4 other locations) |
| Trial ID | NCT07245732 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.