Taper Or Abrupt Steroid Stop: TOASSTtrial

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborators: HEMMI Stiftung Switzerland; Kantonsspital Baselland Bruderholz; Swiss National Science Foundation
• Treatments: Glucocorticoids; Prednisone

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 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