Taper Or Abrupt Steroid Stop: TOASSTtrial
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prednisone
- Placebo Arm
Treatment groups
530 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Basel, Switzerland
Lead sponsor
Kantonsspital Baselland Bruderholz
Collaborator
Swiss National Science Foundation
Collaborator
HEMMI Stiftung Switzerland
Collaborator
Gebauer Stiftung Zurich
Collaborator
Source ClinicalTrials.gov