Comparing Rapid Stop vs. Gradual Reduction of Prednisone in Adults with Autoimmune or Inflammatory Disorders

What this Trial Is About

Researchers are evaluating the safety and effects of stopping systemic glucocorticoid treatment quickly compared to gradually reducing the dose over 4 weeks in patients with inflammatory or autoimmune disorders. This trial is a placebo-controlled, multicenter, randomized study designed to compare rapid termination with a tapering regimen of prednisone. It aims to determine if abrupt stopping is not worse than tapering in terms of patient outcomes over six months. Participants will be randomly assigned to one of two groups one group will receive prednisone with decreasing doses over 4 weeks following a specific tapering schedule, while the other group will stop glucocorticoid treatment abruptly and receive a matching placebo over the same period. Both patients and study staff will be unaware of the treatment allocation. The trial includes a stimulation test at the start, and patients will receive education on managing stress and symptoms related to low cortisol. Follow-up visits will occur mostly by phone at days 7, 35, 90, and 180 to ensure safety and monitor progress. During the study, participants will be monitored for time to any incidence related to glucocorticoid withdrawal up to 6 months, with additional outcomes including health status, symptoms of low cortisol, and hospital stay length if applicable. Safety is a priority with early visits after stopping treatment and emergency medication provided. Researchers will also assess test performance and glucocorticoid doses taken for relapse or adrenal failure treatment. The total follow-up duration for participants is six months.

Taper Or Abrupt Steroid Stop: TOASSTtrial