NCT06072768 Dynamic Treatment Regiments for Glucocorticoid Tapering
| NCT ID | NCT06072768 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2023-03-09 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Beth Wallace, MD MSc
PRINCIPAL INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Frequently Asked Questions
Who can join the NCT06072768 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06072768 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06072768 currently recruiting?
Yes, NCT06072768 is actively recruiting participants. Contact the research team at Olivia.Dickinson@va.gov for enrollment information.
Where is the NCT06072768 trial being conducted?
This trial is being conducted at Ann Arbor, United States, Ann Arbor, United States.
Who is sponsoring the NCT06072768 clinical trial?
NCT06072768 is sponsored by VA Office of Research and Development. The principal investigator is Beth Wallace, MD MSc at VA Ann Arbor Healthcare System, Ann Arbor, MI. The trial plans to enroll 200 participants.
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