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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Prednisone
DrugThe 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.
Placebo Arm
Other interventionThe experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.
Treatment groups
530 Participants
are divided into 2 treatment groupsGroup A: Placebo arm (intervention arm)Placebo comparator 1 intervention
Group B: Verum group (control/standard arm)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to any incidence
Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia \[serum sodium \< 135 millimole (mM)\], hyperkalemia \[serum potassium \> 5 mM\], hypoglycemia \[plasma glucose \< 3.5 mM\]); whichever occurs first.
Time frame
up to 6 monthsSecondary outcomes
1
Time to specific incidence
Time to first occurrence of individual components of the primary outcome;
Time frame
up to 6 months2
Cumulative overall systemic glucocorticoid dose
Cumulative overall systemic glucocorticoid dose
Time frame
up to 6 months3
Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure
Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure
Time frame
up to 6 months4
Cumulative systemic glucocorticoid dose administered to treat relapse
Cumulative systemic glucocorticoid dose administered to treat relapse of disease, specified for each disease
Time frame
up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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