Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering
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
Description
This trial was changed, so that participants could participate remotely without coming into the clinic. For participants coming into the clinic, the clinical disease activity index (CDAI) will be used to measure objective intolerance to tapering. For remote participants, the Rheumatoid Arthritis Disease Activity Index (RADAI) will be used instead of the CDAI.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 di…
Interventions
- Drug15-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.
- Drug150-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, MIAnn Arbor, Michigan
- University of MichiganAnn Arbor, Michigan