Taper Or Abrupt Steroid Stop: TOASSTtrial

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• Main ID: NCT03153527
• Date of registration: 05/05/2017
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Taper Or Abrupt Steroid Stop: TOASSTtrial TOASST
• Scientific title: Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial
• Date of first enrolment: May 31, 2017
• Target sample size: 573
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03153527
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Jonas Rutishauser, Prof MD
• Affiliation: Departement Medizin, Kantonsspital Baden

• Name: Jonas Rutishauser, Prof MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune

Inflammatory Disorder

Intervention(s)

Drug: Prednisone

Other: Placebo Arm

Primary Outcome(s)

Time to any incidence [Time Frame: up to 6 months]

Secondary Outcome(s)

General health status [Time Frame: assessed at days 1, 7, 28, 35, 90,180]

Score of symptoms and signs of hypocortisolism [Time Frame: up to 6 months]

Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure [Time Frame: up to 6 months]

Performance in 250 mcg Synacthen® test [Time Frame: up to 6 months]

Cumulative systemic glucocorticoid dose administered to treat relapse [Time Frame: up to 6 months]

In patients hospitalized at study entry: length of hospital stay [Time Frame: up to 6 months]

Cumulative overall systemic glucocorticoid dose [Time Frame: up to 6 months]

Time to specific incidence [Time Frame: up to 6 months]

Secondary ID(s)

2016-00487; ex14Rutishauser

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kantonsspital Baselland Bruderholz

HEMMI Stiftung Switzerland

Swiss National Science Foundation