Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome

RECORDATI GROUP103 enrolled

Overview

This is a multi-centre, observational, non-comparative, retrospective cohort study designed to evaluate the long-term safety and effectiveness of osilodrostat in non-CD CS patients. Patients treated with oral osilodrostat regardless of the duration of their treatment will be followed retrospectively for up to 36 months after initiating osilodrostat.

Study Type

OBSERVATIONAL

Enrollment

103

Conditions

Cushing's Syndrome

Interventions

OsilodrostatDRUG

oral administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female patients ≥18 years old with diagnosis of CS, except for CD (i.e., an aetiology of adrenal adenoma, adrenocortical carcinoma, adrenal hyperplasia, or ectopic adrenocorticotropic hormone secretion). Patients should have a contemporaneously documented diagnosis of CS as per effective guidelines. 2. Patients treated with osilodrostat between April 2019 and study start date as part of ATU programme or commercialisation. Exclusion Criteria: 1. Patients who participated in a clinical trial anytime during the study period. 2. Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.

Locations (1)

Hôpital Haut-Lévèque

Pessac, France

Outcomes

Primary Outcomes

Effectiveness of Osilodrostat

Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)

Time frame: at week 12

Secondary Outcomes

Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC)

Proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN) by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.

Time frame: at weeks 18, 24, 36, 48, 60, and 72

Long Term Effects of Osilodrostat on Morning Serum Cortisol

Proportion of patients with normal measures of morning serum cortisol \[≤ upper normal limit (ULN)\] by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.

Time frame: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72

Long-term Effects of Osilodrostat on Composite Cortisol Measure

Proportion of patients with normal response of composite cortisol (salivary cortisol, urinary cortisol and morning serum cortisol) \[≤ upper normal limit (ULN)\] by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.

Time frame: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72

Data from ClinicalTrials.gov

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