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RECRUITING
NCT06072768
PHASE2

Dynamic Treatment Regiments for Glucocorticoid Tapering

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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