Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
University Hospital Frankfurt
RECRUITING
Frankfurt
University Hospital Würzburg
RECRUITING
Würzburg
Switzerland
Departement of Internal Medicine, Kantonsspital Aarau
RECRUITING
Aarau
Kantonsspital Baden
RECRUITING
Baden
Endocrinology/Diabetology/Metabolism; University Hospital Basel
RECRUITING
Basel
Department of Rheumatology, Immunology, and Allergology, Inselspital
RECRUITING
Bern
Division of Gastroenterology, Spital Bülach AG
RECRUITING
Bülach
Kantonsspital Frauenfeld
RECRUITING
Frauenfeld
Geneva University Hospitals
RECRUITING
Geneva
Center for Primary Health Care,University of Basel, Kantonsspital Baselland
RECRUITING
Liestal
Internal Medicine, Kantonsspital Baselland/Liestal
RECRUITING
Liestal
Department of Internal Medicine, Kantonsspital Münsterlingen
RECRUITING
Münsterlingen
Stoffwechselzentrum, Kantonsspital Olten
RECRUITING
Olten
Department of Internal Medicine, Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Dept. of Endocrinology, Diabetology and Clinical Nutrition, University Hospital
RECRUITING
Zurich
Contact Information
Primary
Jonas Rutishauser, Prof MD
j.rutishauser@unibas.ch
+41-56-486 25 16
Time Frame
Start Date: 2017-05-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 573
Treatments
Placebo_comparator: Placebo arm (intervention arm)
Stop glucocorticoid treatment; administer placebo matching the verum preparation in weekly intervals.
Active_comparator: Verum group (control/standard arm)
If patient is on \> 7.5 mg prednisone-equivalent daily: administer 7.5 mg q.d. for 7 days, then 5 mg q.d. for 7 days, then 2.5 mg q.d. for 7 days, then 2.5 mg q.d. every second day, then stop. If patient on 7.5 mg q.d.: maintain for 7 days, then taper as above.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland
Collaborators: Swiss National Science Foundation, HEMMI Stiftung Switzerland, Kantonsspital Baselland Bruderholz