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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02875184

Acronym

REWARD

Enrollment

200

Registered

2016-08-23

Start date

2017-03-06

Completion date

2022-06-30

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Psoriatic

Keywords

Psoriatic Arthritis, Apremilast, CC-10004

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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 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 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
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.

Countries

Netherlands

Outcome results