Recruiting

Methylprednisolone & Prednisone

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07245732

Conditions

Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Glucocorticoid (GC)

Study Details

Brief summary:

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.

Conditions

Rheumatoid Arthritis (RA)

Study ID

NCT07245732

Start date

Apr, 2026

Status verified date

Oct, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral

Oral steroid arm: Prednisone 15 mg/day for a week, reducing by 5 mg/day every 7 days until tapered off

experimental: Intramuscular

Single dose 120 mg intramuscular methylprednisolone to the deltoid

Interventions

Glucocorticoid (GC)

  • PO GC arm: Prednisone 15 mg/day for a week, reducing by 5 mg/day every 7 days until tapered off
  • IM GC arm: Single dose 120 mg IM methylprednisolone to the deltoid

Primary outcome measure

  • Rheumatoid Arthritis Flare Questionnaire (RA-FQ) [ Time Frame: Weeks 0, 1, 2, 4, 6 (primary outcome at 6-weeks) ]

Central Contacts and Locations

Central contacts

Timothy S.H. Kwok, MD, MSc, FRCPC

416-480-4580timothysh.kwok@utoronto.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Sharron Sandhu, MB ChB BAO, MScCH, MRCP

416-480-4580Sharron.Sandhu@sunnybrook.ca

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Lauren King, MD, PhD, FRCPC

416-864-5420l.king@utoronto.ca

Women's College Hospital

Recruiting

Toronto, Ontario, Canada, M5S 1B2

Contacts

Natasha Gakhal, MD, MSc, FRCPC

416-323-6344Natasha.Gakhal@wchospital.ca

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Vinod Chandran, MBBS MD DM PhD

416-603-5192Vinod.Chandran@uhnresearch.ca

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5T 3L9

Contacts

Bindee Kuriya, MD, SM, FRCPC

Bindee.Kuriya@sinaihealth.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 13, 2026

Last verified

Oct, 2025

Keywords

  • Pragmatic trial
  • Qualitative study
  • Study within a trial (SWAT)
  • Steroids
  • Rheumatoid arthritis
  • Quality of life
  • Disease flare
  • Patient reported outcomes
  • Adverse effects

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-04-13.