Observational Study of Apremilast in Patients With Psoriasis in The Netherlands
APRIL
1 other identifier
observational
154
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2016
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2016
CompletedFirst Posted
Study publicly available on registry
January 12, 2016
CompletedStudy Start
First participant enrolled
February 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMay 13, 2024
July 1, 2020
3.9 years
January 8, 2016
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points
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
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 Outcomes (9)
Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment
Up to approximately 12 months
Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey
Up to approximately 12 months
Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D)
Up to approximately 12 months
Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS)
Up to approximately 12 months
Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment
Up to approximately 2 months
- +4 more secondary outcomes
Study Arms (1)
Patients receiving Apremilast per daily clinical practice
Dutch patients receiving Apremilast according to daily clinical practice
Eligibility Criteria
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.
You may qualify if:
- Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
- Patients starting treatment for psoriasis with apremilast in clinical practice.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (12)
Zorggroep Twente
Hengelo, Gelderland, 7555 DL, Netherlands
Radboud UMC
Nijmegen, Gelderland, 6525 GL, Netherlands
Zuyderland MC
Sittard, Limburg, 6162 BG, Netherlands
Bravis Ziekenhuis
Bergen op Zoom, North Brabant, 4624 VT, Netherlands
Amphia
Breda, North Brabant, 4818 CK, Netherlands
TweeSteden Ziekenhuis
Tilburg, North Brabant, 5042 AD, Netherlands
Maxima MC
Veldhoven, North Brabant, 5504 DB, Netherlands
Centrum Oosterwal
Alkmaar, North Holland, 1817 MS, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, 2134 TM, Netherlands
Antonius Ziekenhuis Sneek
Sneek, Provincie Friesland, 8601 DZ, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079 DZ, Netherlands
Meander MC
Amsersfoort, Utrecht, 3813 TZ, Netherlands
Related Publications (1)
van den Reek JMPA, van der Leest RJT, Thomas SE, Prevoo R, Plantenga ME, de Jong EMGJ. Improved Quality of Life in Patients with Psoriasis Receiving Apremilast: Real-World Data from the Netherlands. Adv Ther. 2024 Apr;41(4):1594-1605. doi: 10.1007/s12325-023-02759-9. Epub 2024 Feb 24.
PMID: 38402373BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2016
First Posted
January 12, 2016
Study Start
February 22, 2016
Primary Completion
December 31, 2019
Study Completion
June 30, 2020
Last Updated
May 13, 2024
Record last verified: 2020-07