A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
- Conditions
- Arthritis, Psoriatic
- Registration Number
- NCT02875184
- Lead Sponsor
- Amgen
- Brief Summary
This is a multicenter, prospective, non-interventional, observational single arm study.
100 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 Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.
- Detailed Description
The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Not provided
- Refusal to participate in the study.
- Language barrier for completing the questionnaires.
- Women who are pregnant or breast-feeding.
- Hypersensitivity to the active substance or to any of the excipients.
- Prior exposure to apremilast
- Initiation of apremilast treatment by a dermatologist for psoriasis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline Up to 24 months The HAQ is a general questionnaire to assess physical functioning.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points Up to 24 months The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.
Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months Up to 12 months EQ-5D is a standard instrument to measure of health status.
Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point Up to 24 months PsAID is a general questionnaire that measures the health impact of psoriatic arthritis.
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6 Up to 6 months The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis.
Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6 Up to 6 months The DLQI is a dermatology specific Quality of Life instrument.
Change from Baseline in Short Form 36 (SF36) at 12 months Up to 12 months The SF-36v2® Health Survey measures functional health and well-being from the patients point of view. It can be used across age (18 and older), disease and treatments.
Change from Baseline in visual analogue scales (VAS) at various time point Up to 24 months VAS is a simple assessment of the global health, itch and pain severity using a visual analogue scale
Trial Locations
- Locations (11)
MC Leeuwarden
🇳🇱Leeuwarden, Friesland, Netherlands
Research Site
🇳🇱Venlo, Netherlands
Reumazorg ZWN
🇳🇱Goes, Zeeland, Netherlands
Elkerliek ziekenhuis
🇳🇱Helmond, North-Brabant, Netherlands
Groene Hart Ziekenhuis
🇳🇱Gouda, South-Holland, Netherlands
Viecuri Medisch Centrum
🇳🇱Venlo, Limburg, Netherlands
Beatrix Ziekenhuis
🇳🇱Gorinchem, South-Holland, Netherlands
Amphia
🇳🇱Breda, North-Brabant, Netherlands
Erasmus MC
🇳🇱Rotterdam, South-Holland, Netherlands
Maasstad Ziekenhuis
🇳🇱Rotterdam, South-Holland, Netherlands
St. Jansdal
🇳🇱Harderwijk, Gelderland, Netherlands