Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency

PHASE4RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

June 7, 2022

Primary Completion Date

October 1, 2025

Study Completion Date

March 1, 2028

Conditions
Adrenal InsufficiencyPolymyalgia RheumaticaGiant Cell Arteritis
Interventions
DRUG

Hydrocortisone

Patients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA , prednisolone is not part of the intervention.

DRUG

Placebo for hydrocortisone

Patients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA , prednisolone is not part of the intervention.

Trial Locations (3)

2100

RECRUITING

Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet, Copenhagen

Unknown

NOT_YET_RECRUITING

Department of Endocrinology, Aarhus University Hospital, Aarhus

NOT_YET_RECRUITING

Department of Endocrinology, Odense University Hospital, Odense

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Odense University Hospital

OTHER

lead

Ulla Feldt-Rasmussen

OTHER

NCT05435781 - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency | Biotech Hunter | Biotech Hunter