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Dynamic Treatment Regiments for Glucocorticoid Tapering
Sponsor: VA Office of Research and Development
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
Official title: Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-03-09
Completion Date
2030-03-01
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
15-day taper prednisone
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
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.
Locations (2)
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
University of Michigan
Ann Arbor, Michigan, United States