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

October 9, 2023 updated by: Amgen

Observational 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.

Study Overview

Status

Completed

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).

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Breda, Netherlands, 4818 CK
        • Research Site
      • Gorinchem, Netherlands, 4204 AA
        • Research Site
      • Gouda, Netherlands, 2803 HH
        • Research Site
      • Harderwijk, Netherlands, 3844 DG
        • Research Site
      • Leeuwarden, Netherlands, 8934 AD
        • Research Site
      • Roosendaal, Netherlands, 4707 CH
        • Research Site
      • Rotterdam, Netherlands, 3015 CE
        • Research Site
      • Rotterdam, Netherlands, 3079 DZ
        • Research Site
      • Venlo, Netherlands, 5912 BL
        • Research Site
    • Flevoland
      • Lelystad/Emmeloord, Flevoland, Netherlands, 8233GT / 8303 BX
        • Reumazorg ZWN
    • Friesland
      • Leeuwarden, Friesland, Netherlands, 8934 AD
        • MC Leeuwarden
    • Gelderland
      • Harderwijk, Gelderland, Netherlands, 3844DG
        • St. Jansdal
    • Limburg
      • Venlo, Limburg, Netherlands, 5912 BL
        • VieCuri Medisch Centrum
    • Noord-Brabant
      • Roosendaal, Noord-Brabant, Netherlands, 4707 CH
        • Reumazorg ZWN
    • North-Brabant
      • Breda, North-Brabant, Netherlands, 4819 EV
        • Amphia
      • Helmond, North-Brabant, Netherlands, 5707 HA
        • Elkerliek Ziekenhuis
    • South-Holland
      • Gorinchem, South-Holland, Netherlands, 4204 AA
        • Beatrix Ziekenhuis
      • Gouda, South-Holland, Netherlands, 2803 HH
        • Groene Hart Ziekenhuis
      • Rotterdam, South-Holland, Netherlands, 3015 CE
        • Erasmus MC
      • Rotterdam, South-Holland, Netherlands, 3079 DZ
        • Maasstad ziekenhuis
    • Zeeland
      • Goes, Zeeland, Netherlands, 4462 EV
        • Reumazorg ZWN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Two hundred adult patients treated with apremilast for psoriatic arthritis will be recruited. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Psoriatic arthritis patients treated with apremilast
Psoriatic arthritis patients who are treated with apremilast according to daily practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 months
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.
Up to 24 months
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.
Up to 6 months
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.
Up to 6 months
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.
Up to 12 months
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.
Up to 12 months
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2017

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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