Observational Study of Apremilast in Patients With Psoriasis in The Netherlands (APRIL)

May 10, 2024 updated by: Amgen

Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

154

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

  • Netherlands
    • Friesland
      • Sneek, Friesland, Netherlands, 8601 DZ
        • Antonius Ziekenhuis Sneek
    • Gelderland
      • Hengelo, Gelderland, Netherlands, 7555 DL
        • Zorggroep Twente
      • Nijmegen, Gelderland, Netherlands, 6525 GL
        • Radboud UMC
    • Limburg
      • Sittard, Limburg, Netherlands, 6162 BG
        • Zuyderland MC
    • North Brabant
      • Tilburg, North Brabant, Netherlands, 5042 AD
        • TweeSteden Ziekenhuis
    • North-Brabant
      • Bergen op Zoom, North-Brabant, Netherlands, 4624 VT
        • Bravis Ziekenhuis
      • Breda, North-Brabant, Netherlands, 4818 CK
        • Amphia
      • Veldhoven, North-Brabant, Netherlands, 5504 DB
        • Máxima MC
    • North-Holland
      • Alkmaar, North-Holland, Netherlands, 1817 MS
        • Centrum Oosterwal
      • Hoofddorp, North-Holland, Netherlands, 2134 TM
        • Spaarne Gasthuis
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3079 DZ
        • Maasstad Ziekenhuis
    • Utrecht
      • Amsersfoort, Utrecht, Netherlands, 3813 TZ
        • Meander MC

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Two hundred adult patients treated with apremilast for psoriasis in clinical practice. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into the study.

Description

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

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients receiving Apremilast per daily clinical practice
Dutch patients receiving Apremilast according to daily clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 12 months
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.
Up to approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 12 months
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.
Up to approximately 12 months
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
Up to approximately 12 months
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
Up to approximately 12 months
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).
Up to approximately 2 months
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.
Up to approximately 12 months
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
Up to approximately 12 months
Baseline characteristics of patients initiating apremilast treatment
Time Frame: Up to approximately 1 month
Characteristics at baseline of patient initiating apremilast treatment
Up to approximately 1 month
Reasons for discontinuation of apremilast
Time Frame: Up to approximately 12 months
Rate and reasons for discontinuation of apremilast within 12 months of start
Up to approximately 12 months

Collaborators and Investigators

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

Sponsor

Amgen

Investigators

  • 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)

February 22, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimated)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-10004-PSOR-014

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.

Clinical Trials on Psoriasis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe