Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorMarianne Christina Klose
About this trial
In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 50 years
Women must be postmenopausal (FSH is measured at the screening visit)
A diagnosis of PMR/GCA, or both conditions combined.
Treatment with prednisolone ≥12 weeks
Disqualifiers
Known primary or secondary adrenal insufficiency
Known Cushing's Syndrome
Known allergy towards study medication ingredients
Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate <30 mL/min (Chronic kidney disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known severe immune deficiency; A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrocortisone
DrugPatients 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.
Placebo for hydrocortisone
DrugPatients 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.
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: RCT group - hydrocortisoneActive comparator 1 intervention
Group B: RCT group - placeboPlacebo comparator 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20) General Fatigue scale, adjusted for EMA
EMA in situations of stress. EMA reporting will be conducted electronically on a smartphone.
Time frame
In situations of stress, participants are asked to answer the EMA items 5 times daily at semi-randomised time points, for 3 days. Diurnal profiles are generated and one diurnal profile summarizes responses during the day across all 'sick-days'.Secondary outcomes
1
Daily 'end-of-day' app-facilitated patient reported outcome (PRO) assessments
Key secondary outcome - obtain information about intercurrent illness, injury, or stress, and symptoms of fatigue, nausea, and general malaise. The questions about symptoms originate from the Danish version of the PRO-CTCAE.
Time frame
Patients are asked daily throughout the study period as 'end-of-day' assessments.2
SF-36
Key secondary outcome
Time frame
At baseline, 3 months and 6 months3
AddiQol-30
Key secondary outcome
Time frame
At baseline, 3 months and 6 months4
PMR/GCA treatment characteristics -accumulated glucocorticoid dose
Key secondary outcome. accumulated glucocorticoid dose
Time frame
Information from 6 months before baseline to end-of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Marianne Christina Klose
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Source ClinicalTrials.gov