Taper Or Abrupt Steroid Stop: TOASSTtrial

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · May 11, 2017

Keywords

ClinConnect Summary

The TOASST trial is studying two different ways to stop treatment with steroid medications, specifically glucocorticoids, which are often used to manage inflammatory and autoimmune conditions. The trial is comparing a quick stop of the medication to a gradual reduction over four weeks to see which method is safer and more effective for patients. This research is being conducted at multiple locations and is currently looking for participants.

To be eligible for the trial, you need to be at least 18 years old and have been taking a daily dose of glucocorticoids for at least 28 days. You should also have been on a dose of 7.5 mg or more of prednisone (a common glucocorticoid) during that time. However, individuals with certain health conditions, such as primary adrenal failure or those who are pregnant or breastfeeding, cannot participate. If you choose to join the trial, you will receive either the quick stop or the tapering method, and doctors will closely monitor your health throughout the study to ensure your safety.

Gender

ALL

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 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