NCT07245732RecruitingPhase 4
Oral Versus Intramuscular Steroid Use to Control Rheumatoid Arthritis Flares
STeroid Options for RA Management (STORM-RA): Oral Versus Intramuscular Steroid Use to Control Rheumatoid Arthritis Flares: A Pragmatic Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
People living with rheumatoid arthritis (RA) often experience flares-periods where their symptoms suddenly get worse. These flares can cause significant pain, make it harder to move and do daily activities, and lower overall quality of life. Doctors often treat flares with medications called glucocorticoids (GCs), which reduce inflammation. These medications can be taken by mouth (oral/PO) or given as a single injection into the muscle (intramuscular/IM). However, it's not clear which option works better from the patient's point of view-especially when it comes to relief of symptoms, improvements in function, and satisfaction with treatment. Most research so far has focused on how well the drugs control the disease, rather than how they impact the patient's overall experience. Research Questions: 1. Does a single GC injection work just as well as taking pills over a few weeks in improving symptoms reported by patients? 2. How do the two treatments compare in terms of symptom relief, ability to function, and patient satisfaction? 3. What do patients think and feel about using GCs to treat RA flares? What the Investigators Think: The investigators believe that a one-time GC injection is just as good as taking pills for a few weeks when it comes to managing RA flares. In fact, the injection might even be safer and preferred by patients. What the Investigators are Doing: The investigators will study 220 adults with RA who are currently having a flare (with at least 3 swollen and tender joints). These patients will be recruited from rheumatology clinics at the University of Toronto and must not have used GCs in the past month. They will be randomly assigned to receive either: A single injection (Methylprednisolone 120 mg), or Oral pills (Prednisone starting at 15 mg daily and tapering down over 3 weeks). The main thing the investigators will look at is how much better patients feel after 6 weeks, based on a questionnaire designed to measure RA flares. The investigators will also look at how well they function, how satisfied they are with the treatment, and whether they had any side effects. In addition, 20 patients (10 from each group) will be interviewed to understand their experiences and opinions about flare treatment in more detail. Why This Is Possible: The investigators have already surveyed University of Toronto rheumatologists who support the idea and provided input on study design. The investigators have also partnered with experts in research methods, national arthritis organizations, and patient groups to make sure the study is relevant and meaningful. Ethics approval has been obtained. Why It Matters: RA flares can have a major impact on people's lives. While current treatments help control inflammation, the investigators need to better understand how these treatments affect people from their own perspective. This study will shift the focus to what matters most to patients, helping doctors and patients choose the best treatment based not only on medical results but also on the patient's experience. This could lead to more effective and personalized care for people living with RA.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- Apr 2026
- Primary completion date
- Mar 2029
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07245732
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 220
- From Apr 2026 to the primary completion date, Mar 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received systemic or intra-articular GC within 4-weeks of randomization.
Other illness
- Allergies, intolerances or contraindications to systemic GCs or IM injections
- Patients with active malignancy, are pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto Western Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Women's College Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.