Observational Study of Apremilast in Patients With Psoriasis in The Netherlands (APRIL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02652494|
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : February 28, 2018
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.
|Condition or disease|
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:
- 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|
|Estimated Enrollment :||200 participants|
|Official Title:||Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands|
|Actual Study Start Date :||February 22, 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Patients receiving Apremilast per daily clinical practice
Dutch patients receiving Apremilast according to daily clinical practice
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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).
- 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.
- 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
- Baseline characteristics of patients initiating apremilast treatment [ Time Frame: Up to approximately 1 month ]Characteristics at baseline of patient initiating apremilast treatment
- Reasons for discontinuation of apremilast [ Time Frame: Up to approximately 12 months ]Rate and reasons for discontinuation of apremilast within 12 months of start
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652494
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|Antonius Ziekenhuis Sneek||Recruiting|
|Sneek, Friesland, Netherlands, 8601 DZ|
|Hengelo, Gelderland, Netherlands, 7555 DL|
|Nijmegen, Gelderland, Netherlands, 6525 GL|
|Sittard, Limburg, Netherlands, 6162 BG|
|Tilburg, North Brabant, Netherlands, 5042 AD|
|Bravis Ziekenhuis||Not yet recruiting|
|Bergen op Zoom, North-Brabant, Netherlands, 4624 VT|
|Breda, North-Brabant, Netherlands, 4818 CK|
|Veldhoven, North-Brabant, Netherlands, 5504 DB|
|Alkmaar, North-Holland, Netherlands, 1817 MS|
|Spaarne Gasthuis||Not yet recruiting|
|Hoofddorp, North-Holland, Netherlands, 2134 TM|
|Rotterdam, South Holland, Netherlands, 3079 DZ|
|Meander MC||Not yet recruiting|
|Amsersfoort, Utrecht, Netherlands, 3813 TZ|
|Study Director:||Jan Pander, PHD||Celgene|