RECRUITING

Dynamic Treatment Regiments for Glucocorticoid Tapering

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering

Quick Facts

Study Start:2023-03-09
Study Completion:2030-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06072768

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Ability to take oral medication and be willing to adhere to the study intervention regimen
  4. * Diagnosis of rheumatoid arthritis by a medical provider, confirmed by checking medical records.
  5. * 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
  6. 1. Eligible DMARDs include the following: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab, sarilumab, rituximab, tofacitinib, baricitinib, upadacitinib
  7. 2. Patients enrolling in the 15-day taper must be taking 7.5mg/day oral prednisone
  8. 3. Patients enrolling in the 150-day taper must be taking 5mg/day oral prednisone
  1. * 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.
  2. * Pre-existing primary or secondary adrenal insufficiency diagnosed by a physician, given high risk of worsening with prednisone taper
  3. * Treatment with another investigational drug or intervention within 90 days
  4. * Pregnancy
  5. * 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)
  6. * 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);
  7. * Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol

Contacts and Locations

Study Contact

Olivia B Dickinson, BA
CONTACT
(734) 548-2987
Olivia.Dickinson@va.gov
Beth Wallace, MD MSc
CONTACT
(804) 370-7807
Beth.Wallace@va.gov

Principal Investigator

Beth Wallace, MD MSc
PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Beth Wallace, MD MSc, PRINCIPAL_INVESTIGATOR, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-09
Study Completion Date2030-03-01

Study Record Updates

Study Start Date2023-03-09
Study Completion Date2030-03-01

Terms related to this study

Keywords Provided by Researchers

  • Disease-modifying anti-rheumatic drug
  • Oral prednisone
  • Dose reduction
  • Tapering

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis