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

NCT04031027 | Completed FDA Drug

• 2 other identifiers: CC-10004-PSOR-026U1111-1236-1175
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 16

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 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.

Conditions

Plaque Psoriasis

Keywords

apremilast; DARWIN; dermatology; retrospective; observational; psoriasis; cross-sectional

Outcome Measures

Primary Outcomes (11)

• Mean age of the patients treated with apremilast

  Age at treatment initiation (years)

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)

• Gender frequency of the patients treated with apremilast

  Gender (male/female); frequency in %

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Mean body weight of the patients treated with apremilast

  Body weight in kg

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Mean body mass index of the patients treated with apremilast

  BMI (combined outcome of weight and height in the form of kg/m\^2)

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Mean blood pressure of the patients treated with apremilast

  Blood pressure in mmHg

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Mean duration of psoriatic disease of the patients treated with apremilast

  Duration in years

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Mean Psoriasis area severity index score of the patients treated with apremilast

  Psoriasis area severity index score (PASI)

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Mean Body surface area of the patients treated with apremilast

  Psoriasis-involved body surface area (BSA) in %

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Mean Physician global assessment (PGA) score of the patients treated with apremilast

  Physician global assessment (PGA)

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Frequency of previous antipsoriatic treatments in the patients treated with apremilast

  Previous treatments classes in %

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

• Reasons for discontinuation of previous antipsoriatic treatments in the patients treated with apremilast

  Frequency distribution of reasons in %

  At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

Secondary Outcomes (11)

• Proportion of participants receiving apremilast at enrollment visit

  Up to approximately 7 months after treatment initiation

• Apremilast treatment duration

  Up to approximately 7 months after treatment initiation

• Change from baseline in Body Surface Area (BSA)

  Up to approximately 7 months after treatment initiation

• Change from baseline in the Physician Global Assessment (PGA) Score

  Up to approximately 7 months after treatment initiation

• Change from baseline in the Dermatology Life Quality Index (DLQI) score

  Up to approximately 7 months after treatment initiation

Interventions

Apremilast DRUG

Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.

Also known as: Otezla; CC-10004

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Adult patients ≥18 years * Moderate to severe plaque-type psoriasis according to Summary of Product Characteristics

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (16)

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

Ancona, AN, 60126, Italy

Location

UOC Dermatologia ASST Spedali Civili

Brescia, BS, 25123, Italy

Location

Dermatologia Azienda Ospedaliera Papardo

Messina, ME, 98158, Italy

Location

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

Bari, 70124, Italy

Location

UOS Clinica Dermatologica Ospedale San Giovanni di Dio

Cagliari, 09123, Italy

Location

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

Catania, 95100, Italy

Location

UOC Dermatologia Arcispedale Sant'Anna

Cona, 44124, Italy

Location

Dermatologia Ospedale Piero Palagi

Florence, 50025, Italy

Location

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

Messina, 98125, Italy

Location

Dermatologia A.O.U. Federico II

Napoli, 80131, Italy

Location

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

Napoli, 80138, Italy

Location

Dermatologia A.O.U. Maggiore della Carità

Novara, 28100, Italy

Location

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

Palermo, 90127, Italy

Location

Clinica Dermatologica Policlinico Tor Vergata

Roma, 00133, Italy

Location

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

Roma, 00161, Italy

Location

UOC Dermatologia Universitaria Ospedale A. Fiorini

Terracina, 04019, Italy

Location

Related Publications (1)

• Giofre C, Fabbrocini G, Potenza C, Tiberio R, Gisondi P, Marasca C, Nuzzo CMA, Benincasa E, Bianchi L; DARWIN study group. Real-World Apremilast Use for Treatment of Plaque Psoriasis in Italy: Patient Perspective, Characteristics, and Clinical Outcomes from the DARWIN Study. Adv Ther. 2023 Jul;40(7):3021-3037. doi: 10.1007/s12325-023-02516-y. Epub 2023 May 12.

  PMID: 37171752 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2019
• First Posted: July 24, 2019
• Study Start: July 22, 2019
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

IT (16)