A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands

Amgen200 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Arthritis, Psoriatic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criter * Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form. * Patients starting treatment with apremilast for psoriatic arthritis. Exclusion Criteria: * 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

Locations (21)

Reumazorg ZWN

Lelystad/Emmeloord, Flevoland, Netherlands

St. Jansdal

Harderwijk, Gelderland, Netherlands

Outcomes

Primary Outcomes

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

The HAQ is a general questionnaire to assess physical functioning.

Time frame: Up to 24 months

Secondary Outcomes

Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point

PsAID is a general questionnaire that measures the health impact of psoriatic arthritis.

Time frame: Up to 24 months

Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points

The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.

Time frame: Up to 24 months

Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6

The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis.

Time frame: Up to 6 months

Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6

The DLQI is a dermatology specific Quality of Life instrument.

Time frame: Up to 6 months

Change from Baseline in Short Form 36 (SF36) at 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.

Time frame: Up to 12 months

Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months

Data from ClinicalTrials.gov

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