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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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).

Detailed Summary:
Sponsor: Shire

Current Primary Outcome:

  • 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


Original Primary Outcome:

  • Incidence of intercurrent illness [ Time Frame: 5 years ]
  • Incidence of adrenal crisis [ Time Frame: 5 years ]
  • Incidence of serious adverse events [ Time Frame: 5 years ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shire

Dates:
Date Received: August 6, 2012
Date Started: August 2012
Date Completion: August 2019
Last Updated: January 26, 2017
Last Verified: January 2017