RecruitingPhase 4NCT03153527

Taper Or Abrupt Steroid Stop: TOASSTtrial

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

Sponsor

University Hospital, Basel, Switzerland

Enrollment

530 participants

Start Date

May 31, 2017

Study Type

INTERVENTIONAL

Conditions

Autoimmune Inflammatory Disorder

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo Arm and a drug called Prednisone for people with autoimmune and inflammatory disorder. The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years and older.

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.

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Interventions

DRUGPrednisone

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.

OTHERPlacebo Arm

The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.

Locations(16)

University Hospital Frankfurt

Frankfurt, Germany

University Hospital Würzburg

Würzburg, Germany

Departement of Internal Medicine, Kantonsspital Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

Endocrinology/Diabetology/Metabolism; University Hospital Basel

Basel, Switzerland

St. Claraspital Basel

Basel, Switzerland

Department of Rheumatology, Immunology, and Allergology, Inselspital

Bern, Switzerland

Division of Gastroenterology, Spital Bülach AG

Bülach, Switzerland

Kantonsspital Frauenfeld

Frauenfeld, Switzerland

Geneva University Hospitals

Geneva, Switzerland

Center for Primary Health Care,University of Basel, Kantonsspital Baselland

Liestal, Switzerland

Internal Medicine, Kantonsspital Baselland/Liestal

Liestal, Switzerland

Department of Internal Medicine, Kantonsspital Münsterlingen

Münsterlingen, Switzerland

Stoffwechselzentrum, Kantonsspital Olten

Olten, Switzerland

Department of Internal Medicine, Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Dept. of Endocrinology, Diabetology and Clinical Nutrition, University Hospital

Zurich, Switzerland

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NCT03153527

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