Taper Or Abrupt Steroid Stop: TOASSTtrial — TOASST  

Autoimmune Clinical Trial

Official title: Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial

Status Recruiting

Clinical Trial Summary

This study is an Investigator-initiated, placebo-controlled, multicenter noninferiority trial, comparing rapid termination of systemic glucocorticoid treatment with a tapering regime over 4 weeks.

Clinical Trial Description

In total, 573 patients will be enrolled. Patients will be randomly assigned in a 1:1 ratio to either prednisone in decreasing doses over 4 weeks or placebo.

Patients, treating physicians, and study personnel will be blinded to treatment allocation to either prednisone or matching placebo. At inclusion, we will perform a 250 micrograms Synacthen® stimulation test. The results of the test will be blinded to treating physicians and investigators, and its value to predict clinical outcome will only be assessed after completion of the trial. As a safety measure, all patients will be instructed about stress coverage as well as signs and symptoms of hypocortisolism and will be provided with emergency medication. Patients will be randomized to the standard (tapering) or the experimental (matching placebo) arm. Follow-up will be for six months. In order to improve adherence to the study and ensure feasibility, follow-up visits in most study centers will be by telephone only. Visits will be performed early after stopping glucocorticoids in both arms (i.e. at days 7 and 35) to ensure safety; the other two visits will be on days 90 and 180.

Amendment approved in 1-2018: former exclusion criterion 'status post organ transplantation' was revised and deleted ;

Related Conditions & MeSH terms

• Autoimmune
• Inflammatory Disorder

• NCT number: NCT03153527
• Study type: Interventional
• Source: University Hospital, Basel, Switzerland
• Contact: Jonas Rutishauser, Prof MD
• Phone: +41-56-486 25 16
• Email: j.rutishauser@unibas.ch
• Status: Recruiting
• Phase: Phase 4
• Start date: May 31, 2017
• Completion date: December 2024