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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 30 (15-day taper) or day 180 (150-day taper group)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met