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Plaque PsoriasisDARWINNCT04031027

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

An observational study of Plaque Psoriasis, run by Amgen at 16 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
Apremilast
How many people
184 participants
Where
16 sitesItaly
Study dates
22 Jul 2019to 27 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Italy16 sites

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

    Ancona, AN, 60126

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

    Bari, 70124

  • UOC Dermatologia ASST Spedali Civili

    Brescia, BS, 25123

  • UOS Clinica Dermatologica Ospedale San Giovanni di Dio

    Cagliari, 09123

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

    Catania, 95100

  • UOC Dermatologia Arcispedale Sant'Anna

    Cona, 44124

  • Dermatologia Ospedale Piero Palagi

    Florence, 50025

  • Dermatologia Azienda Ospedaliera Papardo

    Messina, ME, 98158

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

    Messina, 98125

  • Dermatologia A.O.U. Federico II

    Naples, 80131

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

    Naples, 80138

  • Dermatologia A.O.U. Maggiore della Carità

    Novara, 28100

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

    Palermo, 90127

  • Clinica Dermatologica Policlinico Tor Vergata

    Roma, 00133

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

    Roma, 00161

  • UOC Dermatologia Universitaria Ospedale A. Fiorini

    Terracina, 04019

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Apremilast
Keywords
apremilast, DARWIN, dermatology, retrospective, observational, psoriasis, cross-sectional
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApremilastDrug

    Also called Otezla; CC-10004

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean age of the patients treated with apremilast

    Age at treatment initiation (years)

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

  2. Gender frequency of the patients treated with apremilast

    Gender (male/female); frequency in %

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

  3. Mean body weight of the patients treated with apremilast

    Body weight in kg

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

  4. Mean body mass index of the patients treated with apremilast

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

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

  5. Mean blood pressure of the patients treated with apremilast

    Blood pressure in mmHg

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

  6. Mean duration of psoriatic disease of the patients treated with apremilast

    Duration in years

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

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

    Psoriasis area severity index score (PASI)

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

  8. Mean Body surface area of the patients treated with apremilast

    Psoriasis-involved body surface area (BSA) in %

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

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

    Physician global assessment (PGA)

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

  10. Frequency of previous antipsoriatic treatments in the patients treated with apremilast

    Previous treatments classes in %

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

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

    Frequency distribution of reasons in %

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

Secondary outcomes (11)

  1. Proportion of participants receiving apremilast at enrollment visit

    Persistence on apremilast treatment will be measured up to approximately 7 months after treatment initiation

    Measured: Up to approximately 7 months after treatment initiation

  2. Apremilast treatment duration

    Apremilast treatment duration is defined as the difference between the start date and the end date of apremilast treatment.

    Measured: Up to approximately 7 months after treatment initiation

  3. Change from baseline in Body Surface Area (BSA)

    BSA is measurement of the body area involved in relation to the whole body surface.

    Measured: Up to approximately 7 months after treatment initiation

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

    A 4 to 6-point scoring system used to assess plaque psoriasis disease severity

    Measured: Up to approximately 7 months after treatment initiation

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

    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.

    Measured: Up to approximately 7 months after treatment initiation

  6. Proportions of patients achieving PGA score 0 or 1

    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.

    Measured: Up to approximately 7 months after treatment initiation

  7. Proportions of patients achieving DLQI score ≤5

    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.

    Measured: Up to approximately 7 months after treatment initiation

  8. Proportions of patients achieving ≥4 points improvement in DLQI score

    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.

    Measured: Up to approximately 7 months after treatment initiation

  9. Adverse Events (AEs)

    Descriptive analysis of AEs will be provided by severity, causality and seriousness

    Measured: Up to approximately 7 months after treatment initiation

  10. Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score

    The TSQM-9 is a self-administrated instrument to understand a subject's satisfaction on the current therapy

    Measured: Up to approximately 7 months after treatment initiation

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

    The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases.

    Measured: Up to approximately 7 months after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2019
  2. Study start22 Jul 2019
  3. Primary completion27 Jan 2021
  4. Study completion27 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04031027
Sponsor's protocol ID
CC-10004-PSOR-026
Other IDs
U1111-1236-1175
Acronym
DARWIN
Status last verified
Mar 2024
First submitted
6 Jul 2019
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 37171752

Questions about this trial

What is this clinical trial studying?

An observational study of Plaque Psoriasis, run by Amgen at 16 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean age of the patients treated with apremilast (time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04031027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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