Taper Or Abrupt Steroid Stop: TOASSTtrial
Condition(s) studied
Investigational drug(s) / intervention(s)
Prednisone: The control intervention (standard treatment) consists of prednisone treatment in decreasing doses, starting with 7.5 mg q.d. and reducing the dose every 7 days, such that prednisone treatment is stopped after a total of 4 weeks.
Placebo Arm: The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.
Study 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.
Eligibility
Primary outcome measure(s)
- Time to any incidence — up to 6 months
Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia \[serum sodium \< 135 millimole (mM)\], hyperkalemia \[serum potassium \> 5 mM\], hypoglycemia \[plasma glucose \< 3.5 mM\]); whichever occurs first.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Frankfurt | Frankfurt | Germany | Recruiting |
| University Hospital Würzburg | Würzburg | Germany | Recruiting |
| Departement of Internal Medicine, Kantonsspital Aarau | Aarau | Switzerland | Recruiting |
| Kantonsspital Baden | Baden | Switzerland | Recruiting |
| Endocrinology/Diabetology/Metabolism; University Hospital Basel | Basel | Switzerland | Terminated |
| St. Claraspital Basel | Basel | Switzerland | Recruiting |
| Department of Rheumatology, Immunology, and Allergology, Inselspital | Bern | Switzerland | Terminated |
| Division of Gastroenterology, Spital Bülach AG | Bülach | Switzerland | Terminated |
| Kantonsspital Frauenfeld | Frauenfeld | Switzerland | Recruiting |
| Geneva University Hospitals | Geneva | Switzerland | Recruiting |
| Center for Primary Health Care,University of Basel, Kantonsspital Baselland | Liestal | Switzerland | Terminated |
| Internal Medicine, Kantonsspital Baselland/Liestal | Liestal | Switzerland | Recruiting |
| Department of Internal Medicine, Kantonsspital Münsterlingen | Münsterlingen | Switzerland | Recruiting |
| Stoffwechselzentrum, Kantonsspital Olten | Olten | Switzerland | Terminated |
| Department of Internal Medicine, Kantonsspital St. Gallen | Sankt Gallen | Switzerland | Recruiting |
| Dept. of Endocrinology, Diabetology and Clinical Nutrition, University Hospital | Zurich | Switzerland | Terminated |
On this site
📄 Deltasone (prednisone) drug profile →More University Hospital, Basel, Switzerland trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03153527 on ClinicalTrials.gov ↗ ← All trials in Germany