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

This study is currently recruiting participants.

See

Contacts and Locations

Verified January 2017 by Shire

Sponsor:

ClinicalTrials.gov Identifier:

NCT01661387

First Posted: August 9, 2012

Last Update Posted: January 27, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Information provided by (Responsible Party):

Shire

Purpose

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
Chronic Adrenal Insufficiency


Study Type:	Observational
Study Design:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: familial glucocorticoid deficiency

Genetic and Rare Diseases Information Center resources: Hypoadrenalism 21-hydroxylase Deficiency Congenital Adrenal Hyperplasia

U.S. FDA Resources

Further study details as provided by Shire:

Primary Outcome Measures:

Incidence of intercurrent illness [ Time Frame: 5 years ]
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
Incidence of adrenal crisis [ Time Frame: 5 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 [ Time Frame: 5 years ]
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI


Estimated Enrollment:	3000
Study Start Date:	August 2012
Estimated Study Completion Date:	August 2019
Estimated Primary Completion Date:	August 2019 (Final data collection date for primary outcome measure)

Groups/Cohorts
Plenadren Modified release hydrocortisone
Other Glucocorticoid Replacement Therapy

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661387

Contacts


Contact: Shire Contact		protocol0918400@shire.com
Contact: Shire Transparency		clinicaltransparency@shire.com

Locations


Germany
Charité - Universitätsmedizin Berlin	Recruiting
Berlin, Germany, 10117
Contact: Kathrin Zopf 0049 30450 51 4019 Kathrin.Zopf@charite.de
Principal Investigator: Tina Kienitz
Endokrinologiepraxis am Stuttgarter Platz	Recruiting
Berlin, Germany, 10627
Contact: Kathrin Zopf 0049 302132004 praxis@endokrinologie-charlottenburg.de
Principal Investigator: Marcus Quinkler
Friedrich Alexander Universitat Erlangen Nurnberg	Recruiting
Erlangen, Germany, 91054
Contact: Monika Lindenberg 0049 9131853-5223 monika.lindenberg@uk-erlangen.de
Principal Investigator: Flavius Zoicas
Universitätsklinikum Frankfurt	Recruiting
Frankfurt, Germany, 60590
Contact: Maria Sandler 0049 069 6301 7818 maria.sandler@kgu.de
Principal Investigator: Klaus Badenhoop
LMU Klinikum der Universität München	Recruiting
Munchen, Germany, 80336
Contact: Susanne Schmid 0049 89 5160 5 2414 Susanne_Schmid@med.uni-muenchen.de
Principal Investigator: Felix Beuschlein
Max Planck Institute für Psychiatrie	Recruiting
Munchen, Germany, 80804
Contact: E Stettberger 0049 89 3062 2593 stettberger@mpipsukl.mpg.de
Principal Investigator: Gunter Stalla
Medicover Oldenburg MVZ	Recruiting
Oldenburg, Germany, 26122
Contact: Smadar Pahl 00 49 441 218 460 s.pahl@endokrin-ol.de
Principal Investigator: Michael Droste
Endokrinologiezentrum Ulm Praxis	Not yet recruiting
Ulm, Germany, 89073
Contact: Gwendolin Etzrodt-Walter info@endokrinologie-ulm.de
Principal Investigator: Gwendolin Etzrodt-Walter
Universitätsklinikum Würzburg	Recruiting
Wuerzburg, Germany, 97080
Contact: Martina Zink 0049 93120139968 zink_m@klinik.uni-wuerzburg.de
Principal Investigator: Stephanie Hahner
Italy
Università degli Studi Federico II	Not yet recruiting
Napoli, Italy, 80131
Principal Investigator: Rosario Pivonello
Policlinico Umberto I	Not yet recruiting
Rome, Italy, 00161
Principal Investigator: Andrea Isidori
Policlinico Universitario Agostino Gemelli	Not yet recruiting
Rome, Italy, 00168
Contact: Salvatore Corsello corsello.sm@mclink.it
Principal Investigator: Salvatore Corsello
Netherlands
Universitair Medisch Centrum Groningen	Recruiting
Groningen, Netherlands, 9700
Contact: Mariska Groeneveld 0031503612987 m.a.groeneveld@umcg.nl
Principal Investigator: Andre van Beek
Erasmus MC	Recruiting
Rotterdam, Netherlands, 3015
Contact: Sjaan Poldermans b.poldermans@erasmusmc.nl
Principal Investigator: Richard Feelders
Universitair Medisch Centrum Utrecht	Recruiting
Utrecht, Netherlands, 3584
Contact: Marjolijn Peltenburg mpeltenb@umcutrecht.nl
Principal Investigator: Pierre Zelissen
Sweden
Sahlgrenska Universitetssjukhuset	Recruiting
Gothenborg, Sweden, 413 45
Contact: Kristina Cid Käll 004631471249 kristina.cid.kall@vgregion.se
Principal Investigator: Anna Nilsson
Universitetssjukhuset i Linköping	Recruiting
Linkoping, Sweden, 58185
Contact: Sofia Sjoberg 0046703822234 sofia.k.sjoberg@regionostergotland.se
Principal Investigator: Bertil Ekman
United Kingdom
Queen Elizabeth Hospital	Recruiting
Birmingham, United Kingdom, B12 2TT
Contact: Niki Karavitaki 0044 1214 158 715 niki.karavitaki@uhb.nhs.uk
Principal Investigator: Nikki Karavitaki
St James University Hospital	Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Julie Lynch 0044113 20 64660 julie.lynch5@nhs.net
Principal Investigator: Robert Murray
Barts and The London NHS Trust	Recruiting
London, United Kingdom, EC1A 7BE
Contact: Jane Pheby 0044 20 7882 5660 j.m.pheby@qmul.ac.uk
Principal Investigator: William Drake
Royal Free Hospital	Completed
London, United Kingdom, NW3 2QG
Christie Hospital	Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Victoria Hutchinson 0044 (0)161 446 8132 Victoria.Hutchinson@christie.nhs.uk
Principal Investigator: Peter Trainer
Royal Victoria Infirmary	Recruiting
Newcastle, United Kingdom, NE1 4LP
Contact: Margaret Morris 0044 0191 282 0462 margaret.morris@nuth.nhs.uk
Principal Investigator: Simon Pearce
Churchill Hospital	Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Violet Fazal-Sanderson 00441865 857266 violet.sanderson@ouh.nhs.uk
Principal Investigator: Ashley Grossman

Sponsors and Collaborators

Shire

Investigators


Study Director:	Shire Physician	Shire

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01661387 History of Changes
Other Study ID Numbers:	Protocol 0918-400
First Submitted:	August 6, 2012
First Posted:	August 9, 2012
Last Update Posted:	January 27, 2017
Last Verified:	January 2017

Keywords provided by Shire:


Adrenal insufficiency DuoCort Congenital adrenal hyperplasia (CAH) Modified release Hydrocortisone

Additional relevant MeSH terms:


Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Hydrocortisone Epinephrine Racepinephrine Epinephryl borate Anti-Inflammatory Agents Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents

To Top