RecruitingPhase 2NCT06072768

Dynamic Treatment Regiments for Glucocorticoid Tapering

Using SMART Design to Develop Dynamic Treatment Regimens for Glucocorticoid Tapering

Sponsor

VA Office of Research and Development

Enrollment

200 participants

Start Date

Mar 9, 2023

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the best way to gradually taper (reduce) prednisone — a steroid — in people with rheumatoid arthritis (RA) who are also taking another RA medication. Long-term steroid use has side effects, and this trial aims to find the safest, most effective tapering schedule. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis - You are currently taking oral prednisone AND at least one other FDA-approved RA treatment - You can read and speak English - You are able to take oral medications and follow the study schedule **You may NOT be eligible if...** - You have serious infections or other conditions that complicate steroid management - You are pregnant or planning to become pregnant during the study - You have recently changed your RA medications - You are unable to commit to the study visits and procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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, MI

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06072768

Related Trials

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

NCT076079646 locations

A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

NCT0697244697 locations

Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

NCT0381634552 locations

Study of GS-0151 in Participants With Rheumatoid Arthritis

NCT0690251935 locations

A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)

NCT0736359015 locations