Steroids for Rheumatoid Arthritis

(STORM-RA Trial)

Not yet recruiting at 4 trial locations

Overseen By Bindee Kuriya, MD, SM, FRCPC

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: csDMARDs, tsDMARDs, bDMARDs

Must not be taking: Systemic GCs

Disqualifiers: Active malignancy, pregnant, breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to manage flare-ups in people with rheumatoid arthritis (RA), focusing on patient feelings and functionality. It compares two options: a one-time steroid shot versus steroid pills taken over a few weeks. The goal is to determine which method more effectively improves patient well-being and daily life. Participants should have RA, be experiencing a flare with at least three swollen and tender joints, and not have used steroids in the past month. By gathering patient feedback, the study aims to guide more personalized treatments for RA flares. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping to understand its benefits for more patients.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications like NSAIDs and DMARDs as long as the doses have been stable for a certain period before joining the trial. However, you must not have used glucocorticoids in the past month.

What is the safety track record for these treatments?

Research has shown that both injection and pill forms of glucocorticoids (GCs) are generally well-tolerated by people with rheumatoid arthritis (RA). One study found that a single injection of methylprednisolone (a type of GC) significantly reduced pain for up to 12 weeks, effectively managing symptoms without frequent doses.

For oral prednisone, research indicates it is safe for short-term use. When taken for a few weeks, it does not significantly increase the risk of serious side effects, though some individuals might notice slight weight gain.

Overall, both treatments are considered safe for people with RA, especially when used as directed to manage flare-ups. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for rheumatoid arthritis because they offer unique delivery methods for steroids. The intramuscular option involves a single dose of 120 mg methylprednisolone injected directly into the muscle, potentially offering rapid relief with just one visit, which is a significant departure from the usual daily oral steroid regimens. Meanwhile, the oral treatment involves a tapering dose of prednisone starting at 15 mg/day, which provides a structured approach to reduce inflammation without long-term use. These methods could offer more personalized and potentially more convenient options compared to the traditional continuous low-dose oral steroids.

What evidence suggests that this trial's treatments could be effective for rheumatoid arthritis?

Research has shown that glucocorticoids can effectively relieve pain and improve symptoms in people with rheumatoid arthritis (RA). In this trial, participants will receive either an intramuscular injection of methylprednisolone or oral prednisone. Studies on intramuscular methylprednisolone indicate that patients report a 50% improvement in symptoms within four weeks. Other research highlights significant improvements in joint symptoms, daily function, and overall quality of life. Additionally, oral prednisone reduces pain and lessens disease severity, with short-term use often leading to remission. Both treatments help manage RA flare-ups, although the method of administration may affect the patient's experience. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with rheumatoid arthritis experiencing a flare, defined by at least 3 swollen and tender joints. Participants must not have used glucocorticoids in the past month and will be recruited from University of Toronto's rheumatology clinics.

Inclusion Criteria

I have been on a stable dose of NSAIDs for at least 2 weeks.

A rheumatologist has confirmed I have rheumatoid arthritis.

I have been on a stable dose of my arthritis medication for at least 8 weeks.

Exclusion Criteria

I have not taken steroids by mouth or injection in the last 4 weeks.

I am not pregnant, breastfeeding, or have an active cancer.

I am allergic or cannot tolerate certain steroids or muscle injections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single intramuscular injection of methylprednisolone or oral prednisone over a 3-week tapering regimen

3 weeks

1 visit (in-person) for injection group, multiple visits for oral group

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measured at 6 weeks

6 weeks

Visits at weeks 0, 1, 2, 4, and 6

Extended Follow-up

Assessment of systemic glucocorticoid use and additional outcomes between 6 and 12 weeks

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glucocorticoid

Trial Overview The study compares two methods of administering glucocorticoids to control RA flares: a single intramuscular injection (Methylprednisolone) versus oral pills (Prednisone) tapered over three weeks. The focus is on symptom relief, functionality, patient satisfaction, and side effects after six weeks.

How Is the Trial Designed?

Group I: Oral Experimental Treatment 1 Intervention

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

Group II: Intramuscular Experimental Treatment 1 Intervention

Single dose 120 mg intramuscular methylprednisolone to the deltoid

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

The Physicians' Services Incorporated Foundation

Collaborator

Trials

165

Recruited

31,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1954635/

Response to intramuscular methyl prednisolone in ... Response (primary outcome) at 4 weeks was a 50% improvement in symptoms as perceived by the patient; responders who relapsed received repeat intramuscular MP ...

2. rmdopen.bmj.com rmdopen.bmj.com/content/6/1/e000536

Glucocorticoids in rheumatoid arthritis: current status and ... Subanalyses of the BeSt study showed that 3 months after intra-articular GCs injection, 50% of joints were no longer swollen. After 1 year, ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790704

Effect of Intramuscular vs Intra-articular Glucocorticoid ... Both injections improved joint symptoms, function, stiffness, patient sport level, and quality of life over the entire 24-week follow-up period.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496724195866

Beneficial effects of a 3-week course of intramuscular ... After 12 months, the arthritis had resolved without the need for DMARDs in 9.9% (11/111) of the patients in the placebo group and in 19.8% (22/111) in the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8742830/

The efficacy of systemic glucocorticosteroids for pain in ... The data suggest that systemic GCs reduce pain outcomes in people with active RA. Heterogeneity between studies was partly explained by duration of GC treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1798053/

Safety of low dose glucocorticoid treatment in rheumatoid ... Safety data from recent randomised controlled clinical trials of low dose glucocorticoid treatment in RA suggest that adverse effects associated with this drug ...

7. academic.oup.com academic.oup.com/rheumatology/article/61/1/76/6313178

efficacy of systemic glucocorticosteroids for pain in rheumatoid ... The data suggest that systemic GCs reduce pain outcomes in people with active RA. Heterogeneity between studies was partly explained by duration ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07245732

Oral Versus Intramuscular Steroid Use to Control ... Primary Outcome Measure The primary outcome measure will focus on the impact of GC therapy on the RA flare experience. We will use the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11131391/

Intramuscular methylprednisolone administration in hand ... A single i.m. injection of methylprednisolone in patients with symptomatic HOA significantly reduced pain up to 12 weeks after administration. ...