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

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ClinicalTrials.gov Identifier: NCT04031027
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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.

Condition or disease Intervention/treatment
Plaque Psoriasis Drug: Apremilast

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 375 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: DARWIN: Description of Apremilast Real World Italian Psoriasis Network - a Multicenter, Observational, Cross-sectional Study to Describe Patient Characteristics and Treatment Pattern
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast


Intervention Details:
  • Drug: Apremilast
    Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.
    Other Name: Otezla; CC-10004


Primary Outcome Measures :
  1. Mean age of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Age at treatment initiation (years)

  2. Gender frequency of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Gender (male/female); frequency in %

  3. Mean body weight of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Body weight in kg

  4. Mean body mass index of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    BMI (combined outcome of weight and height in the form of kg/m^2)

  5. Mean blood pressure of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Blood pressure in mmHg

  6. Mean duration of psoriatic disease of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Duration in years

  7. Mean Psoriasis area severity index score of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Psoriasis area severity index score (PASI)

  8. Mean Body surface area of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Psoriasis-involved body surface area (BSA) in %

  9. Mean Physician global assessment (PGA) score of the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Physician global assessment (PGA)

  10. Frequency of previous antipsoriatic treatments in the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Previous treatments classes in %

  11. Reasons for discontinuation of previous antipsoriatic treatments in the patients treated with apremilast [ Time Frame: At treatment initiation (retrospective analysis, at the earliest 7 months prior enrolment) ]
    Frequency distribution of reasons in %


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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 ScPGA 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031027


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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Italy
SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi Active, not recruiting
Ancona, AN, Italy, 60126
UOC Dermatologia ASST Spedali Civili Recruiting
Brescia, BS, Italy, 25123
Dermatologia Azienda Ospedaliera Papardo Recruiting
Messina, ME, Italy, 98158
UOC Dermatologia Arcispedale Sant'Anna Recruiting
Cona, Italy, 44124
Dermatologia Ospedale Piero Palagi Active, not recruiting
Firenze, Italy, 50025
UOC Dermatologia A.O.U. Policlinico G. Martino Recruiting
Messina, Italy, 98125
UOC Clinica Dermatologica A.O.U. Università della Campania Vanvitelli Active, not recruiting
Napoli, Italy, 80138
Dermatologia A.O.U. Maggiore della Carità Recruiting
Novara, Italy, 28100
UOC Dermatologia e MST A.O.U. Policlinico P. Giaccone Active, not recruiting
Palermo, Italy, 90127
Clinica Dermatologica Policlinico Tor Vergata Recruiting
Roma, Italy, 00133
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Francesca Russo, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04031027     History of Changes
Other Study ID Numbers: CC-10004-PSOR-026
U1111-1236-1175 ( Other Identifier: WHO )
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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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
Keywords provided by Celgene:
apremilast
DARWIN
dermatology
retrospective
observational
psoriasis
cross-sectional
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Thalidomide
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents