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

March 1, 2024 updated by: Amgen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Dermatologica e Venereologia Univ. A.O.U. Consorziale Policlinico
      • Cagliari, Italy, 09123
        • UOS Clinica Dermatologica Ospedale San Giovanni di Dio
      • Catania, Italy, 95100
        • Dermatologia A.O.U. Policlinico-Vittorio Emanuele PO S.Marco
      • Cona, Italy, 44124
        • UOC Dermatologia Arcispedale Sant'Anna
      • Firenze, Italy, 50025
        • Dermatologia Ospedale Piero Palagi
      • Messina, Italy, 98125
        • UOC Dermatologia A.O.U. Policlinico G. Martino
      • Napoli, Italy, 80131
        • Dermatologia A.O.U. Federico II
      • Napoli, Italy, 80138
        • UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli
      • Novara, Italy, 28100
        • Dermatologia A.O.U. Maggiore della Carità
      • Palermo, Italy, 90127
        • UOC Dermatologia e MST A.O.U. Policlinico P. Giaccone
      • Roma, Italy, 00133
        • Clinica Dermatologica Policlinico Tor Vergata
      • Roma, Italy, 00161
        • Dermatologia e Venereologia A.O.U. Policlinico Umberto I
      • Terracina, Italy, 04019
        • UOC Dermatologia Universitaria Ospedale A. Fiorini
    • AN
      • Ancona, AN, Italy, 60126
        • SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi
    • BS
      • Brescia, BS, Italy, 25123
        • UOC Dermatologia ASST Spedali Civili
    • ME
      • Messina, ME, Italy, 98158
        • Dermatologia Azienda Ospedaliera Papardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean age of the patients treated with apremilast
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)
Age at treatment initiation (years)
At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)
Gender frequency of the patients treated with apremilast
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
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
Time Frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Frequency distribution of reasons in %
At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants receiving apremilast at enrollment visit
Time Frame: Up to approximately 7 months after treatment initiation
Persistence on apremilast treatment will be measured up to approximately 7 months after treatment initiation
Up to approximately 7 months after treatment initiation
Apremilast treatment duration
Time Frame: Up to approximately 7 months after treatment initiation
Apremilast treatment duration is defined as the difference between the start date and the end date of apremilast treatment.
Up to approximately 7 months after treatment initiation
Change from baseline in Body Surface Area (BSA)
Time Frame: Up to approximately 7 months after treatment initiation
BSA is measurement of the body area involved in relation to the whole body surface.
Up to approximately 7 months after treatment initiation
Change from baseline in the Physician Global Assessment (PGA) Score
Time Frame: Up to approximately 7 months after treatment initiation
A 4 to 6-point scoring system used to assess plaque psoriasis disease severity
Up to approximately 7 months after treatment initiation
Change from baseline in the Dermatology Life Quality Index (DLQI) score
Time Frame: Up to approximately 7 months after treatment initiation
DLQI is 10-item validated questionnaire used in a wide range of dermatological conditions and across a wide range of disease severity as a quality of life instrument.
Up to approximately 7 months after treatment initiation
Proportions of patients achieving PGA score 0 or 1
Time Frame: Up to approximately 7 months after treatment initiation
The Physician's Global Assessment is a measurement of overall involvement by the investigator at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.
Up to approximately 7 months after treatment initiation
Proportions of patients achieving DLQI score ≤5
Time Frame: Up to approximately 7 months after treatment initiation
DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Up to approximately 7 months after treatment initiation
Proportions of patients achieving ≥4 points improvement in DLQI score
Time Frame: Up to approximately 7 months after treatment initiation
DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Up to approximately 7 months after treatment initiation
Adverse Events (AEs)
Time Frame: Up to approximately 7 months after treatment initiation
Descriptive analysis of AEs will be provided by severity, causality and seriousness
Up to approximately 7 months after treatment initiation
Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score
Time Frame: Up to approximately 7 months after treatment initiation
The TSQM-9 is a self-administrated instrument to understand a subject's satisfaction on the current therapy
Up to approximately 7 months after treatment initiation
Patient Benefit Index for Skin Diseases Score (standard version) (PBI-S) outcome score
Time Frame: Up to approximately 7 months after treatment initiation
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases.
Up to approximately 7 months after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-10004-PSOR-026
  • U1111-1236-1175 (Other Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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