Observational Study of Apremilast in Patients With Psoriasis in The Netherlands
NCT ID: NCT02652494
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
154 participants
OBSERVATIONAL
2016-02-22
2020-06-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients receiving Apremilast per daily clinical practice
Dutch patients receiving Apremilast according to daily clinical practice
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients starting treatment for psoriasis with apremilast in clinical practice.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Zorggroep Twente
Hengelo, Gelderland, Netherlands
Radboud UMC
Nijmegen, Gelderland, Netherlands
Zuyderland MC
Sittard, Limburg, Netherlands
Bravis Ziekenhuis
Bergen op Zoom, North Brabant, Netherlands
Amphia
Breda, North Brabant, Netherlands
TweeSteden Ziekenhuis
Tilburg, North Brabant, Netherlands
Maxima MC
Veldhoven, North Brabant, Netherlands
Centrum Oosterwal
Alkmaar, North Holland, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, Netherlands
Antonius Ziekenhuis Sneek
Sneek, Provincie Friesland, Netherlands
Maasstad Ziekenhuis
Rotterdam, South Holland, Netherlands
Meander MC
Amsersfoort, Utrecht, Netherlands
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Expanded Access for CC-10004
Other Identifiers
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CC-10004-PSOR-014
Identifier Type: -
Identifier Source: org_study_id
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