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

Shire3,258 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

3,258

Conditions

Chronic Adrenal Insufficiency

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (24)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Outcomes

Primary Outcomes

Incidence of intercurrent illness

Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

Time frame: approximately 10 years

Incidence of adrenal crisis

Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

Time frame: approximately 10 years

Incidence of serious adverse events

Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI

Time frame: approximately 10 years

Data from ClinicalTrials.gov

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