Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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∙ 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

‣ Eligible DMARDs include the following: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etanercept, adalimumab, infliximab, golimumab, certolizumab pegol, abatacept, tocilizumab, sarilumab, rituximab, tofacitinib, baricitinib, upadacitinib

⁃ Patients enrolling in the 15-day taper must be taking 7.5mg/day oral prednisone

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
Contact Information
Primary
Olivia B Dickinson, BA
Olivia.Dickinson@va.gov
(734) 548-2987
Backup
Beth Wallace, MD MSc
Beth.Wallace@va.gov
(804) 370-7807
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2030-03-01
Participants
Target number of participants: 200
Treatments
Experimental: 15-day taper prednisone
This will be for 30 days. Participants will be allocated to the 15-day strategy preferentially until enrollment goals have been met; once completing the 15-day strategy, many participants will also be eligible to complete the 150-day strategy, and may subsequently enroll in it if they wish. Participants that are not eligible for the 15-day strategy, but are eligible for the 150-day strategy, will be enrolled in the 150-day strategy.
Experimental: 150-day taper prednisone
This will be for 180 days. Participants who are not eligible for the 15-day strategy, but are eligible for the 150-day strategy, will be enrolled in the 150-day strategy.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: University of Michigan

This content was sourced from clinicaltrials.gov