Dynamic Treatment Regiments for Glucocorticoid Tapering

NCT ID
NCT06072768
Registry status
Recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
VA Office of Research and Development
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering

Enrollment: 200 participants (Estimated).

What is being studied

  • Drug: 15-day taper prednisone
  • Drug: 150-day taper prednisone

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

2 study locations are listed.

Recruiting site status is explicitly provided for 2 locations; 2 are listed as Recruiting.

Countries: United States

  • Michigan, United States: 2

Sample of listed locations

  • University of Michigan — Ann Arbor, Michigan, 48109, United States — Recruiting
  • VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, 48105-2303, United States — Recruiting

Study details

Start date
March 9, 2023
Primary completion date
March 1, 2029
Completion date
March 1, 2030
First posted
October 10, 2023
Collaborators
University of Michigan

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06072768
Registry last updated
November 19, 2025
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT06072768 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Clinical trial FAQ