A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

Sponsor

Shire (Industry)

Overall Status

Terminated

CT.gov ID

NCT01661387

Collaborator

(none)

3,258

Enrollment

Locations

98.8

Actual Duration (Months)

135.8

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Adrenal Insufficiency

Study Design

Study Type:

Observational

Actual Enrollment :

3258 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

Actual Study Start Date :

Aug 7, 2012

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Plenadren Modified release hydrocortisone
Other Glucocorticoid Replacement Therapy

Outcome Measures

Primary Outcome Measures

Incidence of intercurrent illness [approximately 10 years]
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of adrenal crisis [approximately 10 years]
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of serious adverse events [approximately 10 years]
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Charité - Universitätsmedizin Berlin	Berlin	Germany	10117
2	Endokrinologiepraxis am Stuttgarter Platz	Berlin	Germany	10627
3	Friedrich Alexander Universitat Erlangen Nurnberg	Erlangen	Germany	91054
4	Universitätsklinikum Frankfurt	Frankfurt	Germany	60590
5	LMU Klinikum der Universität München	Munchen	Germany	80336
6	Medicover Neuroendokrinologie	Munchen	Germany	81667
7	Medicover Oldenburg MVZ	Oldenburg	Germany	26122
8	Endokrinologiezentrum Ulm Praxis	Ulm	Germany	89075
9	Universitätsklinikum Würzburg	Wuerzburg	Germany	97080
10	Università degli Studi Federico II	Napoli	Italy	80131
11	Policlinico Umberto I	Rome	Italy	00161
12	Policlinico Universitario Agostino Gemelli	Rome	Italy	00168
13	Universitair Medisch Centrum Groningen	Groningen	Netherlands	9713
14	Erasmus MC	Rotterdam	Netherlands	3051
15	Universitair Medisch Centrum Utrecht	Utrecht	Netherlands	3584
16	Sahlgrenska Universitetssjukhuset	Gothenborg	Sweden	413 45
17	Universitetssjukhuset i Linköping	Linkoping	Sweden	58185
18	Queen Elizabeth Hospital	Birmingham	United Kingdom	B15 2TH
19	St James University Hospital	Leeds	United Kingdom	LS9 7TF
20	Barts and The London NHS Trust	London	United Kingdom	EC1A 7BE
21	Royal Free Hospital	London	United Kingdom	NW3 2QG
22	Christie Hospital	Manchester	United Kingdom	M20 4BX
23	Royal Victoria Infirmary	Newcastle	United Kingdom	NE1 4LP
24	Churchill Hospital	Oxford	United Kingdom	OX3 9DU