Understanding how to safely reduce steroid doses in rheumatoid arthritis patients
Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering
PHASE2 · VA Office of Research and Development · NCT06072768
This study is testing how safely and effectively people with rheumatoid arthritis can lower their steroid medication doses and what factors might make it easier or harder for them.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Drugs / interventions | adalimumab, infliximab, golimumab, certolizumab, tocilizumab, sarilumab, rituximab, tofacitinib, baricitinib, upadacitinib, methotrexate, prednisone |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT06072768 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the responses of individuals with rheumatoid arthritis (RA) to gradual tapering of steroid medications like prednisone. It will assess various patient characteristics, including inflammation levels and sensory processing, to determine why some patients experience symptoms during dose reduction while others do not. Participants will either taper prednisone over 15 days or 150 days, with assessments conducted remotely or in-clinic using specific disease activity indices. The study seeks to identify predictors of taper intolerance and effective dose reduction strategies.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with rheumatoid arthritis who are currently using both oral prednisone and another FDA-approved disease-modifying antirheumatic drug without recent changes to their treatment.
Not a fit: Patients who are not currently on a stable regimen of oral prednisone and another DMARD or those with contraindications to tapering may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective tapering strategies for steroid medications in rheumatoid arthritis patients.
How similar studies have performed: While tapering of glucocorticoids has been studied, this specific approach focusing on individual patient responses and characteristics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Ability to read and speak English to allow for written informed consent and patient-reported outcomes measures. * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * 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. * Current use of an RA treatment regimen of both oral prednisone and 1 other Food and Drug Administration-approved disease-modifying antirheumatic drug (DMARD), with no change in this therapy over the past 90 days 1. Eligible DMARDs include the following: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab, sarilumab, rituximab, tofacitinib, baricitinib, upadacitinib 2. Patients enrolling in the 15-day taper must be taking 7.5mg/day oral prednisone 3. Patients enrolling in the 150-day taper must be taking 5mg/day oral prednisone Exclusion Criteria: Current or recent (past year) use of systemic glucocorticoid (oral, intravenous, or intramuscular administration) \>2 weeks for an indication other than RA, to reduce risk of adverse health outcomes related to worsening of the indicated condition * Patients with greater than moderate RA activity as determined by the Clinical Disease Activity Index or by rheumatologist assessment, given high likelihood of taper failure in this population due to increased RA activity alone. * Pre-existing primary or secondary adrenal insufficiency diagnosed by a physician, given high risk of worsening with prednisone taper * Treatment with another investigational drug or intervention within 90 days * Pregnancy * Self-reported medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., schizophrenia, malignancy, psychosis, suicidal ideation, history of substance abuse; note that stable anxiety and depression are NOT exclusions) * Current, recent (within the last 6 months), or habitual use of artificial nails or nail enhancements. (Artificial nails can influence pressure pain sensitivity at the thumbnail); * Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Beth Wallace, MD MSc — VA Ann Arbor Healthcare System, Ann Arbor, MI
- Study coordinator: Olivia B Dickinson, BA
- Email: Olivia.Dickinson@va.gov
- Phone: (734) 548-2987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rheumatoid Arthritis, Disease-modifying anti-rheumatic drug, Oral prednisone, Dose reduction, Tapering