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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Must have understood and voluntarily signed the informed consent and privacy form. 2. Age ≥ 18 years at the time of signing the informed consent and privacy form. 3. Patients with available hospital medical chart since the start of apremilast treatment ('index date'). 4. Diagnosis of plaque psoriasis. 5. 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. 6. Ability to understand (read & write) the Italian language and to follow the study instructions.

Exclusion Criteria:

1. Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial. 2. Started apremilast as part of a clinical trial, or previous apremilast use (prior to the index date).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04031027
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Study Website: View Trial Website
Additional Details

The DARWIN study is anticipated to enroll 375 participants from 28 Italian dermatologic departments and recruitment is expected to take approximately 12 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ancona, AN, Italy

Status

Recruiting

Address

SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi

Ancona, AN, 60126

UOC Dermatologia ASST Spedali Civili, Brescia, BS, Italy

Status

Recruiting

Address

UOC Dermatologia ASST Spedali Civili

Brescia, BS, 25123

Dermatologia Azienda Ospedaliera Papardo, Messina, ME, Italy

Status

Recruiting

Address

Dermatologia Azienda Ospedaliera Papardo

Messina, ME, 98158

Bari, Italy

Status

Recruiting

Address

Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico

Bari, , 70124

Cagliari, Italy

Status

Recruiting

Address

UOS Clinica Dermatologica Ospedale San Giovanni di Dio

Cagliari, , 09123

Catania, Italy

Status

Active, not recruiting

Address

Dermatologia A.O.U. Policlinico-Vittorio Emanuele PO S.Marco

Catania, , 95100

UOC Dermatologia Arcispedale Sant'Anna, Cona, Italy

Status

Recruiting

Address

UOC Dermatologia Arcispedale Sant'Anna

Cona, , 44124

Dermatologia Ospedale Piero Palagi, Firenze, Italy

Status

Recruiting

Address

Dermatologia Ospedale Piero Palagi

Firenze, , 50025

Messina, Italy

Status

Recruiting

Address

UOC Dermatologia A.O.U. Policlinico G. Martino

Messina, , 98125

Dermatologia A.O.U. Federico II, Napoli, Italy

Status

Recruiting

Address

Dermatologia A.O.U. Federico II

Napoli, , 80131

Napoli, Italy

Status

Recruiting

Address

UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli

Napoli, , 80138

Novara, Italy

Status

Recruiting

Address

Dermatologia A.O.U. Maggiore della Carità

Novara, , 28100

Palermo, Italy

Status

Recruiting

Address

UOC Dermatologia e MST A.O.U. Policlinico P. Giaccone

Palermo, , 90127

Roma, Italy

Status

Recruiting

Address

Clinica Dermatologica Policlinico Tor Vergata

Roma, , 00133

Roma, Italy

Status

Recruiting

Address

Dermatologia e Venereologia A.O.U. Policlinico Umberto I

Roma, , 00161

Terracina, Italy

Status

Recruiting

Address

UOC Dermatologia Universitaria Ospedale A. Fiorini

Terracina, , 04019

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