Overview
Sponsor-declared trial summary
Tertiary adrenal insufficiency
We will perform the first placebo-controlled randomised controlled trial (RCT) in patients with polymylgia rheumatic and giant cell arteritis after planned cessation of glucocorticoid treatment. Our study will be the first evidence-based guidance and aid to glucocorticoid-induced adrenal u patients and thus meet an imp…
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 1 Feb 2022 → 12 Jan 2026
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513822-53-00
- EudraCT number
- 2020-006121-65
- ClinicalTrials.gov
- NCT05193396
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
We will perform the first placebo-controlled randomised controlled trial (RCT) in patients with polymylgia rheumatic and giant cell arteritis after planned cessation of glucocorticoid treatment. Our study will be the first evidence-based guidance and aid to glucocorticoid-induced adrenal u patients and thus meet an important need for many thousand patients.
Conditions and MedDRA coding
Tertiary adrenal insufficiency
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Age ≥ 50 years
- A diagnosis of polymyalgia rheumatic or giant cell arteritis in glucocorticoid free remission for >2 week and <12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks
Exclusion criteria 7
- Known primary or secondary adrenal insufficiency
- Known Cushing´s syndrome
- Severe comorbidity
- Alcohol consumption >21 units per week
- Planned major surgery during the study period at study entry
- Use of drugs that interfere with cortisol metabolism/measurements
- Inability to provide written informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Adrenal insufficiency symptoms (AddiQoL-30)
Secondary endpoints 6
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hydrokortison ”Orion”, tabletter
PRD1959653 · Product
- Active substance
- Hydrocortisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 4480 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- 52357
- MA holder
- ORION CORPORATION
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Marianne Skovsager Andersen
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Marianne Skovsager Andersen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 270 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2022-02-01 | 2026-01-12 | 2022-02-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-513822-53-00 | 6.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Hydrokortison | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-12 | Denmark | Acceptable 2024-07-30
|
2024-07-31 |