Stopped: Takeda submitted 900 patient years Interim Analysis to PRAC and requested study to be closed since primary objective had been fulfilled. PRAC agreed and on 17Sep2020 approved closure of EU-AIR Registry. Takeda announced study closure on 31Oct2020.
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).
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Incidence of intercurrent illness
Timeframe: approximately 10 years
Incidence of adrenal crisis
Timeframe: approximately 10 years
Incidence of serious adverse events
Timeframe: approximately 10 years