Ireland
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Recruiting Phase 4

Taper Or Abrupt Steroid Stop: TOASSTtrial

NCT03153527 · tracked via the Priya Life Science Germany tracker
Phase
Phase 4
Started
2017-05-31
Last updated
2026-04-22

Condition(s) studied

Inflammatory DisorderAutoimmune

Investigational drug(s) / intervention(s)

Prednisone →Placebo Arm

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Informed Consent as documented by signature (Appendix Informed Consent Form) * Age ≥ 18 years * Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion * Therapy over ≥ 28 days, ≥ 7.5 mg average daily dose, with a cumulative glucocorticoid dose ≥ 420 mg prednisone-equivalent prior to inclusion * Tapering not or no longer mandatory to treat underlying disease Exclusion Criteria: * Primary adrenal failure * Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural) * Incapability to administer glucocorticoid cover treatment in situations of stress * Inability or unwillingness to provide informed consent * Women who are pregnant or breast feeding, * Intention to become pregnant during the course of the study, * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. * Known or suspected non-compliance * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study, * Enrolment of the investigator, his/her family members, employees and other dependent persons

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)

FacilityCityRegionStatus
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
Official registry record

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