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NCT Number: NCT02875184

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

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.

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Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Reumazorg ZWN, Lelystad/Emmeloord, Flevoland, Netherlands

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: Up to 24 months

    The HAQ is a general questionnaire to assess physical functioning.

Secondary outcomes

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

    Time frame: Up to 24 months

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

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

    Time frame: Up to 24 months

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

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

    Time frame: Up to 6 months

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

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

    Time frame: Up to 6 months

    The DLQI is a dermatology specific Quality of Life instrument.

  5. Change from Baseline in Short Form 36 (SF36) at 12 months

    Time frame: 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.

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

    Time frame: Up to 12 months

    EQ-5D is a standard instrument to measure of health status.

  7. Change from Baseline in visual analogue scales (VAS) at various time point

    Time frame: Up to 24 months

    VAS is a simple assessment of the global health, itch and pain severity using a visual analogue scale

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Acronym: REWARD

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2016
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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