Apremilast
DrugApremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.
Other names: Otezla; CC-10004
NCT Number: NCT04031027
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.
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Notify Me18 year and older
All sexes
Observational
SOD Clinica Dermatologica A.O.U. Riuniti Umberto I Lancisi Salesi, Ancona, AN, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.
Other names: Otezla; CC-10004
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior enrolment)
Age at treatment initiation (years)
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Gender (male/female); frequency in %
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Body weight in kg
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)
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Blood pressure in mmHg
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Duration in years
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Psoriasis area severity index score (PASI)
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Psoriasis-involved body surface area (BSA) in %
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Physician global assessment (PGA)
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Previous treatments classes in %
Time frame: At treatment initiation (retrospective analysis, about 6 (+/-1) months prior prior enrolment)
Frequency distribution of reasons in %
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
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.
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.
Time frame: Up to approximately 7 months after treatment initiation
A 4 to 6-point scoring system used to assess plaque psoriasis disease severity
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.
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.
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.
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.
Time frame: Up to approximately 7 months after treatment initiation
Descriptive analysis of AEs will be provided by severity, causality and seriousness
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
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.
Amgen
Industry
DARWIN: Description of Apremilast Real World Italian Psoriasis Network - a Multicenter, Observational, Cross-sectional Study to Describe Patient Characteristics and Treatment Pattern
Acronym: DARWIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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