RECRUITINGPhase 4INTERVENTIONAL
Taper Or Abrupt Steroid Stop: TOASSTtrial
Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- willing to sign a consent form as documented by signature (Appendix willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Prednisone
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.
OTHER
Placebo 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