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Corticosteroid

Prednisone Taper for Rheumatoid Arthritis (SMART-RA Trial)

Phase 2
Recruiting
Led By Beth Wallace, MD MSc
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to take oral medication and be willing to adhere to the study intervention regimen
Diagnosis of rheumatoid arthritis by a medical provider, confirmed by checking medical records
Must not have
Pre-existing primary or secondary adrenal insufficiency diagnosed by a physician, given high risk of worsening with prednisone taper
High RA disease activity, defined as a Clinical Disease Activity Index of greater (>) 10, given high likelihood of taper failure in this population due to increased RA activity alone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30 (15-day taper) or day 180 (150-day taper group)
Awards & highlights

Summary

This trial seeks to understand why people with RA have different responses to reducing steroid doses. It will look at inflammation, brain info processing and hormone levels.

Who is the study for?
This trial is for adults with rheumatoid arthritis who are currently on a stable RA treatment regimen including oral prednisone and another approved DMARD, without changes in the last 90 days. They must be able to take oral medication, read and speak English, provide consent, and commit to the study duration. Pregnant individuals or those with high RA activity or recent other steroid use are excluded.
What is being tested?
The trial is testing how reducing doses of prednisone over either 15 days or 150 days affects people with rheumatoid arthritis. It aims to understand why some patients experience symptoms when their steroid dose is lowered by examining inflammation levels, sensory processing in the brain, and hormone levels.
What are the potential side effects?
Potential side effects from tapering off steroids like prednisone may include fatigue, joint pain flare-ups, mood swings, changes in blood sugar levels, increased difficulty fighting infections due to immune suppression withdrawal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills and will follow the study's treatment plan.
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I have been diagnosed with rheumatoid arthritis by a doctor.
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I am currently taking 5mg of prednisone daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with adrenal insufficiency.
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My rheumatoid arthritis is highly active, with a CDAI score over 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30 (15-day taper) or day 180 (150-day taper group)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 (15-day taper) or day 180 (150-day taper group) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Net glucocorticoid dose reduction
Number of participants with objective taper intolerance
Number of participants with subjective taper intolerance

Trial Design

2Treatment groups
Experimental Treatment
Group I: 150-day taper prednisoneExperimental Treatment1 Intervention
This will be for 180 days. Participants who are not eligible for the 15-day strategy, but are eligible for the 150-day strategy, will be enrolled in the 150-day strategy.
Group II: 15-day taper prednisoneExperimental Treatment1 Intervention
This will be for 30 days. Participants will be allocated to the 15-day strategy preferentially until enrollment goals have been met; once completing the 15-day strategy, many participants will also be eligible to complete the 150-day strategy, and may subsequently enroll in it if they wish. Participants that are not eligible for the 15-day strategy, but are eligible for the 150-day strategy, will be enrolled in the 150-day strategy.

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,870 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
814 Patients Enrolled for Rheumatoid Arthritis
Beth Wallace, MD MScPrincipal InvestigatorVA Ann Arbor Healthcare System, Ann Arbor, MI
~133 spots leftby Mar 2029
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