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Recruiting Phase 4 NCT03153527

Taper Or Abrupt Steroid Stop: TOASSTtrial

Trial Parameters

Condition Inflammatory Disorder
Sponsor University Hospital, Basel, Switzerland
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 530
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2017-05-31
Completion 2027-06
Interventions
PrednisonePlacebo Arm

Brief 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 Criteria

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 o

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