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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving Apremilast per daily clinical practice | Dutch patients receiving Apremilast according to daily clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zorggroep Twente | Hengelo | Gelderland | 7555 DL | Netherlands | ||
| Radboud UMC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38402373 | Background | 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. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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) | 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) | 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 | 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 | 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 | sPGA: assessment by physician to classify disease activity in a consistent manner | Up to approximately 12 months |
| Baseline characteristics of patients initiating apremilast treatment | Characteristics at baseline of patient initiating apremilast treatment | Up to approximately 1 month |
| Reasons for discontinuation of apremilast | Rate and reasons for discontinuation of apremilast within 12 months of start | Up to approximately 12 months |
| 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 |
| Expanded Access for CC-10004 | View source |