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

November 19, 2020 updated by: Shire

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

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).

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

3258

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10627
        • Endokrinologiepraxis am Stuttgarter Platz
      • Erlangen, Germany, 91054
        • Friedrich Alexander Universität Erlangen Nürnberg
      • Frankfurt, Germany, 60590
        • Universitatsklinikum Frankfurt
      • Munchen, Germany, 80336
        • LMU Klinikum der Universität München
      • Munchen, Germany, 81667
        • Medicover Neuroendokrinologie
      • Oldenburg, Germany, 26122
        • Medicover Oldenburg MVZ
      • Ulm, Germany, 89075
        • Endokrinologiezentrum Ulm Praxis
      • Wuerzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Italy
      • Napoli, Italy, 80131
        • Università degli studi Federico II
      • Rome, Italy, 00161
        • Policlinico Umberto I
      • Rome, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
  • Netherlands
      • Groningen, Netherlands, 9713
        • Universitair Medisch Centrum Groningen
      • Rotterdam, Netherlands, 3051
        • Erasmus MC
      • Utrecht, Netherlands, 3584
        • Universitair Medisch Centrum Utrecht
  • Sweden
      • Gothenborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
      • Linkoping, Sweden, 58185
        • Universitetssjukhuset i Linköping
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, EC1A 7BE
        • Barts and the London NHS Trust
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital
      • Newcastle, United Kingdom, Ne1 4LP
        • Royal Victoria Infirmary
      • Oxford, United Kingdom, OX3 9DU
        • Churchill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Plenadren
Modified release hydrocortisone
Other Glucocorticoid Replacement Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of intercurrent illness
Time Frame: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
approximately 10 years
Incidence of adrenal crisis
Time Frame: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
approximately 10 years
Incidence of serious adverse events
Time Frame: approximately 10 years
Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI
approximately 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 7, 2012

Primary Completion (ACTUAL)

October 31, 2020

Study Completion (ACTUAL)

October 31, 2020

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (ESTIMATE)

August 9, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0918-400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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