Taper Or Abrupt Steroid Stop: TOASSTtrial
Taper Or Abrupt Steroid Stop: TOASSTtrial
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.
In total, 573 patients will be enrolled. Patients will be randomly assigned in a 1:1 ratio to
 either prednisone in decreasing doses over 4 weeks or placebo.

 Patients, treating physicians, and study personnel will be blinded to treatment allocation to
 either prednisone or matching placebo. At inclusion, we will perform a 250 micrograms
 Synacthen® stimulation test. The results of the test will be blinded to treating physicians
 and investigators, and its value to predict clinical outcome will only be assessed after
 completion of the trial. As a safety measure, all patients will be instructed about stress
 coverage as well as signs and symptoms of hypocortisolism and will be provided with emergency
 medication. Patients will be randomized to the standard (tapering) or the experimental
 (matching placebo) arm. Follow-up will be for six months. In order to improve adherence to
 the study and ensure feasibility, follow-up visits in most study centers will be by telephone
 only. Visits will be performed early after stopping glucocorticoids in both arms (i.e. at
 days 7 and 35) to ensure safety; the other two visits will be on days 90 and 180.

 Amendment approved in 1-2018: former exclusion criterion 'status post organ transplantation'
 was revised and deleted
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