Clinical trial NCT01661387: A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
Official title: A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Adrenal Insufficiency
Keywords: Adrenal insufficiency
DuoCort
Congenital adrenal hyperplasia (CAH)
Modified release
Hydrocortisone
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-08-09
Enrollment: 3258
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic adrenal insufficiency (primary or secondary) who are receiving Plenadren or other glucocorticoid replacement therapies at endocrinology centres in certain European countries as part of their routine clinical care. Approximately 20 sites are planned for enrollment.

Brief summary: As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic adrenal insufficiency
* Written informed consent/assent in compliance with applicable country-specific and local regulations

Exclusion Criteria:

* Participation in an interventional clinical trial

Primary outcomes:
measure: Incidence of intercurrent illness
timeFrame: approximately 10 years
measure: Incidence of adrenal crisis
timeFrame: approximately 10 years
measure: Incidence of serious adverse events
timeFrame: approximately 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Endokrinologiepraxis am Stuttgarter Platz
city: Erlangen
country: Germany
facility: Friedrich Alexander Universitat Erlangen Nurnberg
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Munchen
country: Germany
facility: LMU Klinikum der Universität München
city: Munchen
country: Germany
facility: Medicover Neuroendokrinologie
city: Oldenburg
country: Germany
facility: Medicover Oldenburg MVZ
city: Ulm
country: Germany
facility: Endokrinologiezentrum Ulm Praxis
city: Wuerzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Napoli
country: Italy
facility: Università degli Studi Federico II
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Gothenborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Linkoping
country: Sweden
facility: Universitetssjukhuset i Linköping
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Shire
name: Shire Director
role: STUDY_DIRECTOR
References:
citation: Quinkler M, Murray RD, Zhang P, Marelli C, Petermann R, Isidori AM, Ekman B. Characterization of patients with adrenal insufficiency and frequent adrenal crises. Eur J Endocrinol. 2021 May 4;184(6):761-771. doi: 10.1530/EJE-20-1324.
citation: Quinkler M, Ekman B, Zhang P, Isidori AM, Murray RD; EU-AIR Investigators. Mortality data from the European Adrenal Insufficiency Registry-Patient characterization and associations. Clin Endocrinol (Oxf). 2018 Jul;89(1):30-35. doi: 10.1111/cen.13609. Epub 2018 Apr 22.
citation: Murray RD, Ekman B, Uddin S, Marelli C, Quinkler M, Zelissen PM; the EU-AIR Investigators. Management of glucocorticoid replacement in adrenal insufficiency shows notable heterogeneity - data from the EU-AIR. Clin Endocrinol (Oxf). 2017 Mar;86(3):340-346. doi: 10.1111/cen.13267. Epub 2016 Dec 5.
citation: Ekman B, Fitts D, Marelli C, Murray RD, Quinkler M, Zelissen PM. European Adrenal Insufficiency Registry (EU-AIR): a comparative observational study of glucocorticoid replacement therapy. BMC Endocr Disord. 2014 May 9;14:40. doi: 10.1186/1472-6823-14-40.