Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease
Purpose
This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.
Condition
- Cushings Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Written informed consent or equivalent document (e.g., written information) as per country regulation prior to registration of any patient data - Male or female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option - Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry
Exclusion Criteria
- Patients with ectopic ACTH-dependent Cushing's syndrome - Patients with adrenal Cushing's syndrome - Patients with Pseudo Cushing's syndrome
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort 1/new use cohort | Subjects who initiated pasireotide s.c. at time of study entry (on or after the signing of the informed consent or acknowledging an equivalent document -for example, written information- as per country regulation). |
|
| Cohort 2/prior use cohort | Subjects who initiated pasireotide s.c. prior to study entry. |
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More Details
- Status
- Completed
- Sponsor
- RECORDATI GROUP