Taper Or Abrupt Steroid Stop: TOASSTtrial
Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial
University Hospital, Basel, Switzerland
530 participants
May 31, 2017
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria12
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03153527