Dynamic Treatment Regiments for Glucocorticoid Tapering — SMART-RA  

Rheumatoid Arthritis Clinical Trial

Official title: Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT06072768
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Olivia B Dickinson, BA
• Phone: (734) 548-2987
• Email: Olivia.Dickinson@va.gov
• Status: Recruiting
• Phase: Phase 2
• Start date: March 9, 2023
• Completion date: March 1, 2030