Clinical trial NCT02652494: Observational Study of Apremilast in Patients With Psoriasis in The Netherlands
Official title: Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Observational
Apremilast
APRIL
Non-Interventional
The Netherlands
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-01-12
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with Dermatology Life Quality Index (DLQI) ≤ 5 points
timeFrame: Up to approximately 12 months
measure: Percentage of patients with Dermatology Life Quality Index (DLQI) improvement in DLQI ≥ 5 points
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Changes in treatment satisfaction questionnaire for medication (TSQM) at 6 and 12 months treatment
timeFrame: Up to approximately 12 months
measure: Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey
timeFrame: Up to approximately 12 months
measure: Changes in generic quality of life at 6 and 12 months treatment using EuroQol-5 dimensions (EQ-5D)
timeFrame: Up to approximately 12 months
measure: Change in itch at 6 and 12 months treatment using the itch Visual Analog Scale (VAS)
timeFrame: Up to approximately 12 months
measure: Changes in psoriasis area and severity index (PASI) at 6 and 12 months treatment
timeFrame: Up to approximately 2 months
measure: Changes in body surface area (BSA)at 6 and 12 months treatment
timeFrame: Up to approximately 12 months
measure: Changes in static physician global assessment (sPGA) at 6 and 12 months treatment
timeFrame: Up to approximately 12 months
measure: Baseline characteristics of patients initiating apremilast treatment
timeFrame: Up to approximately 1 month
measure: Reasons for discontinuation of apremilast
timeFrame: Up to approximately 12 months
Other outcomes:
Locations:
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis Sneek
state: Friesland
city: Hengelo
country: Netherlands
facility: Zorggroep Twente
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud UMC
state: Gelderland
city: Sittard
country: Netherlands
facility: Zuyderland MC
state: Limburg
city: Tilburg
country: Netherlands
facility: TweeSteden Ziekenhuis
state: North Brabant
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis
state: North-Brabant
city: Breda
country: Netherlands
facility: Amphia
state: North-Brabant
city: Veldhoven
country: Netherlands
facility: Maxima MC
state: North-Brabant
city: Alkmaar
country: Netherlands
facility: Centrum Oosterwal
state: North-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
state: North-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: South Holland
city: Amsersfoort
country: Netherlands
facility: Meander MC
state: Utrecht
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.