NCT07245732

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. 1.Does a single GC injection work just as well as taking pills over a few weeks in improving symptoms reported by patients?
  2. 2.How do the two treatments compare in terms of symptom relief, ability to function, and patient satisfaction?
  3. 3.What do patients think and feel about using GCs to treat RA flares?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
39mo left

Started Apr 2026

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Jul 2029

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

April 13, 2026

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

November 17, 2025

Last Update Submit

April 10, 2026

Conditions

Rheumatoid Arthritis (RA)

Keywords

Pragmatic trialQualitative studyStudy within a trial (SWAT)SteroidsRheumatoid arthritisQuality of lifeDisease flarePatient reported outcomesAdverse effects

Outcome Measures

Primary Outcomes (1)

  • Rheumatoid Arthritis Flare Questionnaire (RA-FQ)

    The Rheumatoid Arthritis Flare Questionnaire (RA-FQ) was created and endorsed in 2016 by OMERACT to assess flare treatment response over time, addressing many of the shortcomings associated with the use of disease activity measure scores to gauge flare evolution. The RA-FQ includes five patient-reported items-pain, physical function, stiffness, fatigue, and participation-rated on an 11-point scale over the past week, producing a total score from 0 to 50, with higher scores indicating worse flare disease activity. Validated for content and construct validity, the RA-FQ is sensitive to change within one week and aligns well with the Clinical Disease Activity Index (CDAI), making it a practical, patient-centered tool with strong clinical relevance.

    Weeks 0, 1, 2, 4, 6 (primary outcome at 6-weeks)

Secondary Outcomes (4)

  • Health Assessment Questionnaire Disability Index (HAQ-DI)

    Weeks 0 and 6

  • Clinical Disease Activity Index (CDAI)

    Weeks 0 and 6

  • Glucocorticoid adverse events

    6-weeks

  • Systemic GC use between 6 and 12 weeks

    6 to 12-weeks

Study Arms (2)

Oral

EXPERIMENTAL

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

Drug: Glucocorticoid (GC)

Intramuscular

EXPERIMENTAL

Single dose 120 mg intramuscular methylprednisolone to the deltoid

Drug: Glucocorticoid (GC)

Interventions

Glucocorticoid (GC)DRUG

* 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

IntramuscularOral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

RECRUITING

Related Publications (16)

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    PMID: 34088713BACKGROUND

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    PMID: 25854489BACKGROUND

  • Nikolic RPA, Pardo JP, Pope JE, Barber CEH, Barnabe C, Schieir O, Jamal S, Legge A, Kuriya B, Akhavan P, Thorne JC, Bombardier C, Taylor-Gjevre R, Bykerk V, Khraishi M, Proulx L, Richards DP, Tugwell P, Agarwal A, Bansback N, Hazlewood GS. Canadian Rheumatology Association Living Guidelines for Rheumatoid Arthritis: Update #2. J Rheumatol. 2024 Sep 1;51(9):940-941. doi: 10.3899/jrheum.2024-0540. No abstract available.

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    PMID: 24357813BACKGROUND

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    PMID: 29417936BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Glucocorticoids

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

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

CONTACT

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

Bindee Kuriya, MD, SM, FRCPC

CONTACT

(416) 586-4800bindee.kuriya@sinaihealth.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

April 13, 2026

Record last verified: 2025-10

Locations

CA(5)