REPLACE - A multi-centre, randomised, double-blinded, placebo controlled 16-weeks study to compare the effect of hydrocortisone and placebo in patients with Giant Cell Arteritis (GCA)/ Polymyalgia Rheumatica (PMR) with patient-reported symptoms of adrenal insufficiency after cessation of glucocorticoid treatment.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513822-53-00

Enrollment

270

Registered

2024-07-31

Start date

2022-02-01

Completion date

Unknown

Last updated

2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tertiary adrenal insufficiency

Brief summary

Adrenal insufficiency symptoms (AddiQoL-30)

Detailed description

Patient reported symptoms of fatigue, questionnaire-based HRQoL other than AddiQoL-30, incidence of adrenal crises, hospitalizations and sick days, Blood pressure and arterial stiffness, Body composition and muscle strength, Metabolic and cardiovascular risk, Bone status, Biological integrated cortisol status assessment

Interventions

DRUGPLACEBO

DRUGHydrokortison ”Orion”

DRUGtabletter

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adrenal insufficiency symptoms (AddiQoL-30)	—

Secondary

Measure	Time frame
Patient reported symptoms of fatigue, questionnaire-based HRQoL other than AddiQoL-30, incidence of adrenal crises, hospitalizations and sick days, Blood pressure and arterial stiffness, Body composition and muscle strength, Metabolic and cardiovascular risk, Bone status, Biological integrated cortisol status assessment	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026