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Completed

NCT Number: NCT02652494

Observational Study of Apremilast in Patients With Psoriasis in The Netherlands

This is a multicenter, prospective, non-interventional, observational single arm study.

Two-hundred patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the SPC of apremilast (Otezla®). Recruitment will continue until 200 patients have entered the study. Each patient will be followed for 12 months.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zorggroep Twente, Hengelo, Gelderland, Netherlands

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About this study

Baseline Demographics, disease characteristics and medication history prior to start of treatment with apremilast will be collected. Patients will be asked to complete baseline DLQI, SF36, EQ5D, TSQM,WPAI and PBI questionnaires. Photographs of the finger nails will be taken.

Follow-up visits Follow-up assessments will take place at the regularly scheduled outpatient visits at 6 and 12 months (+/- 1 month) after initiation of apremilast.

  • Skin-specific disease measures (Psoriasis Activity and Severity Index (PASI), (static) Physician Global Assessment (sPGA), Body Surface Area (BSA))
  • Patients will be asked to complete the following questionnaires:
  • DLQI
  • TSQM
  • EQ5D
  • SF36- Itch Visual Analog Scale (VAS)
  • WPAI Work Productivity and Activity Index
  • Patient Benefit Index PBI

End of treatment Upon discontinuation of treatment with apremilast, the date, the dose and reason for discontinuation will be documented.

AE monitoring All patients will be monitored for adverse events throughout the study.

From the time of the patient signing informed consent until treatment with apremilast is permanently abrogated, all non-serious adverse events that are considered related to apremilast and all Serious Adverse Events (SAEs) regardless of causality will be reported.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
  • Patients starting treatment for psoriasis with apremilast in clinical practice.

Exclusion criteria

  • Refusal to participate in the study.
  • Women who are pregnant or breast-feeding.
  • Hypersensitivity to the active substance or to any of the excipients.
  • Prior exposure to apremilast
  • Psoriatic arthritis treated by a rheumatologist in the previous year

Treatment and study plan

Primary outcomes

  1. Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points

    Time frame: Up to approximately 12 months

    The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.

  2. Percentage of patients with Dermatology Life Quality Index (DLQI) improvement in DLQI ≥ 5 points

    Time frame: Up to approximately 12 months

    The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.

Secondary outcomes

  1. Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment

    Time frame: Up to approximately 12 months

    The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.

  2. Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey

    Time frame: Up to approximately 12 months

    The SF-36v2® Health Survey measures functional health and well-being from the patient's point of view. It can be used across age (18 and older), disease, and treatment group.

  3. Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D)

    Time frame: Up to approximately 12 months

    EQ-5D is a standardized instrument for use as a measure of health outcome in a wide range of health conditions and treatment

  4. Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS)

    Time frame: Up to approximately 12 months

    Itch VAS is a simple assessment of the itch severity using a visual analogue scale

  5. Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment

    Time frame: Up to approximately 2 months

    PASI score is a tool used to measure the severity and extent of psoriasis (Psoriasis Area and Severity Index).

  6. Changes in body surface area (BSA)at 6 and 12 months treatment

    Time frame: Up to approximately 12 months

    BSA (Body Surface Area): severity is defined by how much of the body surface area is affected.

  7. Changes in static physician global assessment (sPGA) at 6 and 12 months treatment

    Time frame: Up to approximately 12 months

    sPGA: assessment by physician to classify disease activity in a consistent manner

  8. Baseline characteristics of patients initiating apremilast treatment

    Time frame: Up to approximately 1 month

    Characteristics at baseline of patient initiating apremilast treatment

  9. Reasons for discontinuation of apremilast

    Time frame: Up to approximately 12 months

    Rate and reasons for discontinuation of apremilast within 12 months of start

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands

Acronym: APRIL

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 12, 2016
Registry last updated
May 13, 2024

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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