NCT04031027

A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice

DARWIN: Description of Apremilast Real World Italian Psoriasis Network - a Multicenter, Observational, Cross-sectional Study to Describe Patient Characteristics and Treatment Pattern

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 184 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 period). DARWIN will describe patients' characteristics in Italian routine clinical practice as well as the medication utilization patterns, including needs and benefits form the patient's perspective.

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 apremilast treatment 6 (±1) months prior enrollment in order to be considered eligible. The decision to prescribe apremilast falls within current practice according to the current decision-making process in the Italian routine clinical practice and according to AIFA prescribing information. No extra-procedures (diagnostic or monitoring) will be implemented and the assessment schedule reflects the routine clinical practice for psoriatic patients treated with apremilast. Patients will be consecutively enrolled in the study and information will be collected as recorded in the medical chart before starting apremilast (as close as possible to the apremilast start date/index date), and/or directly observed during the enrolment visit. The study variables will describe patient disease and characteristics, apremilast utilization patterns, psoriasis severity a, extent and impact on patient wellbeing, apremilast safety profile and apremilast satisfaction.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.

Timeline

• Start date: 2019-07-22
• Primary completion: 2021-01-27
• Completion: 2021-01-27
• First posted: 2019-07-24
• Last updated: 2024-03-04

Locations

16 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study