Dynamic Treatment Regiments for Glucocorticoid Tapering

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT06072768
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 15-day taper prednisone — DRUG
    The 15-day taper group will assess the effect of an approximately 50% oral prednisone dose reduction over 15 days, and will be followed for an additional 15 days after the last dose reduction.
  • 150-day taper prednisone — DRUG
    The 150-day taper group will assess the effect of reducing oral prednisone by 1 milligram (mg) every 30 days over 150 days, and will be followed for an additional 30 days after the last dose reduction.

Study Details

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

Key Dates

Start date
Mar 9, 2023
Status verified
Nov 2025
Primary completion
Mar 1, 2029
Completion
Mar 1, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.

Primary Outcome Measure

Number of participants with subjective taper intolerance [ Time Frame: Day 30 (15-day taper) or day 180 (150-day taper group) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Olivia B Dickinson, BA
[email protected]
734-548-2987
Beth I Wallace, MD
[email protected]
7345319956
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Olivia B Dickinson, BA
[email protected]
734-548-2987
Beth Wallace, MD MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Michigan· Ann Arbor, MIVA Ann Arbor Healthcare System, Ann Arbor, MI· Ann Arbor, MI

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