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Sponsor ID
CC-10004-PSOR-026

A study to describe the characteristics of patients treated with apremilast for plaque psoriasis in Italian routine clinical practiceDARWIN

Sponsor ID
CC-10004-PSOR-026
Clinicaltrials.gov ID
NCT04031027
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
N/A
Type
Observational
Masking
N/A
Enrollment
184
Additional Study Details

Protocol Summary

Primary Outcome Measures

Mean age of the patients treated with apremilast

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

Gender frequency of the patients treated with apremilast

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

Mean body weight of the patients treated with apremilast

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

Mean body mass index of the patients treated with apremilast

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

Mean blood pressure of the patients treated with apremilast

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

Mean duration of psoriatic disease of the patients treated with apremilast

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

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

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

Mean Body surface area of the patients treated with apremilast

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

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

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

Frequency of previous antipsoriatic treatments in the patients treated with apremilast

Timeframe: 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

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

Secondary Outcome Measures

Proportion of participants receiving apremilast at enrollment visit

Timeframe: Up to approximately 7 months after treatment initiation

Apremilast treatment duration

Timeframe: Up to approximately 7 months after treatment initiation

Change from baseline in Body Surface Area (BSA)

Timeframe: Up to approximately 7 months after treatment initiation

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

Timeframe: Up to approximately 7 months after treatment initiation

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

Timeframe: Up to approximately 7 months after treatment initiation

Proportions of patients achieving PGA score 0 or 1

Timeframe: Up to approximately 7 months after treatment initiation

Proportions of patients achieving DLQI score ≤5

Timeframe: Up to approximately 7 months after treatment initiation

Proportions of patients achieving ≥4 points improvement in DLQI score

Timeframe: Up to approximately 7 months after treatment initiation

Adverse Events (AEs)

Timeframe: Up to approximately 7 months after treatment initiation

Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score

Timeframe: Up to approximately 7 months after treatment initiation

Patient Benefit Index for Skin Diseases Score (standard version) (PBI-S) outcome score

Timeframe: Up to approximately 7 months after treatment initiation

Locations

Location
Status
Contact Us
Location
UOC Dermatologia ASST Spedali Civili
Brescia, BS, Italy, 25123
Status
Recruiting
Location
SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi
Ancona, AN, Italy, 60126
Status
Recruiting
Location
Dermatologia A.O.U. Maggiore della Carità
Novara, NO, Italy, 28100
Status
Recruiting
Location
Dermatologia Azienda Ospedaliera Papardo
Messina, ME, Italy, 98158
Status
Recruiting
Location
Clinica Dermatologica Policlinico Tor Vergata
Roma, Italy, 00133
Status
Recruiting
Location
UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli
Napoli, Italy, 80138
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Jul 2019 - Jan 2021
    Inclusion and 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).