Status:
COMPLETED
A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice
Lead Sponsor:
Amgen
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Brief Summary
The DARWIN study is an Italian multicenter, observational, cross-sectional study involving both a primary data collection (at enrollment visit) and secondary use of data (retrospective observation per...
Detailed Description
The DARWIN study is anticipated to enroll 375 participants from 24 Italian dermatologic departments and recruitment is expected to take approximately 20 months. Participants must have started apremila...
Eligibility Criteria
Inclusion
- Must have understood and voluntarily signed the informed consent and privacy form.
- Age ≥ 18 years at the time of signing the informed consent and privacy form.
- Patients with available hospital medical chart since the start of apremilast treatment ('index date').
- Diagnosis of plaque psoriasis.
- Treatment with apremilast for plaque psoriasis, according to Summary of Product Characteristics (SmPC), started 6 (±1) months before enrollment. Patients who interrupted apremilast treatment before enrollment will also be included.
- Ability to understand (read \& write) the Italian language and to follow the study instructions.
Exclusion
- Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial.
- Started apremilast as part of a clinical trial, or previous apremilast use (prior to the index date).
Key Trial Info
Start Date :
July 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 27 2021
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04031027
Start Date
July 22 2019
End Date
January 27 2021
Last Update
March 4 2024
Active Locations (16)
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1
SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi
Ancona, AN, Italy, 60126
2
UOC Dermatologia ASST Spedali Civili
Brescia, BS, Italy, 25123
3
Dermatologia Azienda Ospedaliera Papardo
Messina, ME, Italy, 98158
4
Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico
Bari, Italy, 70124