Actively Recruiting
Dynamic Treatment Regiments for Glucocorticoid Tapering
Led by VA Office of Research and Development · Updated on 2025-11-19
200
Participants Needed
2
Research Sites
364 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
U
University of Michigan
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to better understand how people with rheumatoid arthritis (RA) respond to gradual dose reduction, or "tapering", of steroid medications like prednisone. Some people with RA have symptoms when steroid dose is reduced, while others don't. This trial will look at different patient characteristics, including levels of inflammation in the body, differences in the way the brain processes sensory information, and certain hormone levels, to help researchers better understand why different people have these different responses to steroid tapering. The hypotheses include: * Greater or equal to ( ) 30% of participants in each arm will develop taper intolerance (either subjective, objective, or both) during the study period * Greater or equal to 60% of participants will reduce Glucocorticoid dose by at least 5 Milligrams per day during the study period
CONDITIONS
Official Title
Dynamic Treatment Regiments for Glucocorticoid Tapering
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to read and speak English to provide informed consent and complete patient-reported outcome measures
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Ability and willingness to take oral medication as per study regimen
- Diagnosis of rheumatoid arthritis confirmed by medical provider and records
- Current treatment with oral prednisone plus one other FDA-approved disease-modifying antirheumatic drug (DMARD) without therapy changes in past 90 days
- Eligible DMARDs include hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab, sarilumab, rituximab, tofacitinib, baricitinib, upadacitinib
- For 15-day taper group: taking 7.5 mg/day oral prednisone
- For 150-day taper group: taking 5 mg/day oral prednisone
You will not qualify if you...
- Use of systemic glucocorticoids for more than 2 weeks in the past year for conditions other than rheumatoid arthritis
- Greater than moderate RA activity by Clinical Disease Activity Index or rheumatologist assessment
- Diagnosis of primary or secondary adrenal insufficiency
- Treatment with another investigational drug or intervention within past 90 days
- Pregnancy
- Medical or psychiatric conditions that would prevent participation (e.g., schizophrenia, malignancy, psychosis, suicidal ideation, substance abuse history), except stable anxiety or depression
- Current, recent (past 6 months), or habitual use of artificial nails or nail enhancements
- Any other impairment, activity, behavior, or situation judged by study team to prevent study completion
AI-Screening
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Trial Site Locations
Total: 2 locations
1
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
O
Olivia B Dickinson, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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