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NCT06072768 | RECRUITING | Rheumatoid Arthritis

Dynamic Treatment Regiments for Glucocorticoid Tapering
Sponsor:

VA Office of Research and Development

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

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

15-day taper prednisone

150-day taper prednisone

Phase

PHASE2

Detailed Description:

This trial was changed, so that participants could participate remotely without coming into the clinic. For participants coming into the clinic, the clinical disease activity index (CDAI) will be used to measure objective intolerance to tapering. For remote participants, the Rheumatoid Arthritis Disease Activity Index (RADAI) will be used instead of the CDAI.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Masking Description : None (open label)
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering
Actual Study Start Date : 2023-03-09
Estimated Primary Completion Date : 2029-03-01
Estimated Study Completion Date : 2030-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Dynamic Treatment Regiments for Glucocorticoid Tapering

Location Details

NCT06072768

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Road cancer

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Road cancer, United States, 48105-2303

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48109