Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05193396
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2022-01-02
Brief Title:
Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment
Sponsor:
Marianne Andersen
Organization:
Odense University Hospital
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPLACE
Brief Summary:
Cortisol a glucocorticoid GC hormone secreted from the adrenal glands is essential for survival Cortisol also possesses anti-inflammatory actions and GC formulations prednisolone are used to treat many inflammatory diseases and conditions Indeed three percent of the Danish population 180000 individuals redeems at least one prescription of synthetic GC per year and at least 20000 patients annually discontinue GC treatment Pharmacological GC therapy suppresses endogenous cortisol production and thereby induce relative adrenal insufficiency GIA The risk of GIA as determined by the adrenal corticotrophic hormone ACTH stimulation test has previously been reported to 25 but testing after GC treatment is not routinely performed Indeed we have new and unpublished but persuasive evidence to suggest that the risk of GIA after planned cessation of prednisolone treatment for polymyalgia rheumatic PMR or giant cell arteritis GCA is substantially lower probably 2 The reason for this discrepancy is undoubtedly selection bias in the previous publications and the use of inaccurate cortisol assays At the same time however we observed that 25 exhibited pronounced symptoms of adrenal insufficiency based on a questionnaire specific for detecting symptoms of adrenal insufficiency the so-called AddiQoL-30 Concomitantly the basal cortisol levels in the same group were significantly lower as compared to the group who exhibited milder or no symptoms attributable to adrenal insufficiency This observation aligns with the clinical experience that PMRGCA patients often complain of fatigue after planned cessation of prednisolone treatment This often occurs in the absence of objective symptoms or signs of residual PMRGCA disease activity The scenario has been designated as the steroid withdrawal syndrome We argue that this may represent a state of relative adrenal insufficiency prompted by long term high dose prednisolone treatment The proper way to tackle this clinical conundrum is to perform a proper randomized trial which so far has not been conducted
Therefore we will perform the first placebo-controlled randomised controlled trial RCT in patients with PMR and GCA after planned cessation of GC treatment We argue that neither watchful waiting nor routine hydrocortisone replacement are infallible Our study will be the first evidence-based guidance and aid to GIA patients and thus meet an important need for many thousand patients
Therefore we will perform the first placebo-controlled randomised controlled trial RCT in patients with PMR and GCA after planned cessation of GC treatment We argue that neither watchful waiting nor routine hydrocortisone replacement are infallible Our study will be the first evidence-based guidance and aid to GIA patients and thus meet an important need for many thousand patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None