Observational Study of Apremilast in Patients With Psoriasis in The Netherlands

Psoriasis Clinical Trial

— APRIL  

Official title:

Observational Study of Apremilast Use and Effectiveness Over a One Year Treatment Period in Patients With Psoriasis in The Netherlands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652494
• Other study ID #: CC-10004-PSOR-014
• Status: Completed
• Start date: February 22, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Netherlands	Centrum Oosterwal	Alkmaar	North-Holland
Netherlands	Meander MC	Amsersfoort	Utrecht
Netherlands	Bravis Ziekenhuis	Bergen op Zoom	North-Brabant
Netherlands	Amphia	Breda	North-Brabant
Netherlands	Zorggroep Twente	Hengelo	Gelderland
Netherlands	Spaarne Gasthuis	Hoofddorp	North-Holland
Netherlands	Radboud UMC	Nijmegen	Gelderland
Netherlands	Maasstad Ziekenhuis	Rotterdam	South Holland
Netherlands	Zuyderland MC	Sittard	Limburg
Netherlands	Antonius Ziekenhuis Sneek	Sneek	Friesland
Netherlands	TweeSteden Ziekenhuis	Tilburg	North Brabant
Netherlands	Maxima MC	Veldhoven	North-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Changes in generic quality of life at 6 and 12 months treatment Short Form 36 (SF-36v2) health survey	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Baseline characteristics of patients initiating apremilast treatment	Characteristics at baseline of patient initiating apremilast treatment	Up to approximately 1 month
Secondary	Reasons for discontinuation of apremilast	Rate and reasons for discontinuation of apremilast within 12 months of start	Up to approximately 12 months

External Links

•   AmgenTrials clinical trials website
•   Expanded Access for CC-10004