- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02875184
A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands (REWARD)
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
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Breda, Netherlands, 4818 CK
- Research Site
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Gorinchem, Netherlands, 4204 AA
- Research Site
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Gouda, Netherlands, 2803 HH
- Research Site
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Harderwijk, Netherlands, 3844 DG
- Research Site
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Leeuwarden, Netherlands, 8934 AD
- Research Site
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Roosendaal, Netherlands, 4707 CH
- Research Site
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Rotterdam, Netherlands, 3015 CE
- Research Site
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Rotterdam, Netherlands, 3079 DZ
- Research Site
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Venlo, Netherlands, 5912 BL
- Research Site
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Flevoland
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Lelystad/Emmeloord, Flevoland, Netherlands, 8233GT / 8303 BX
- Reumazorg ZWN
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Friesland
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Leeuwarden, Friesland, Netherlands, 8934 AD
- MC Leeuwarden
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Gelderland
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Harderwijk, Gelderland, Netherlands, 3844DG
- St. Jansdal
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Limburg
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Venlo, Limburg, Netherlands, 5912 BL
- VieCuri Medisch Centrum
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Noord-Brabant
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Roosendaal, Noord-Brabant, Netherlands, 4707 CH
- Reumazorg ZWN
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North-Brabant
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Breda, North-Brabant, Netherlands, 4819 EV
- Amphia
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Helmond, North-Brabant, Netherlands, 5707 HA
- Elkerliek Ziekenhuis
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South-Holland
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Gorinchem, South-Holland, Netherlands, 4204 AA
- Beatrix Ziekenhuis
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Gouda, South-Holland, Netherlands, 2803 HH
- Groene Hart Ziekenhuis
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Rotterdam, South-Holland, Netherlands, 3015 CE
- Erasmus MC
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Rotterdam, South-Holland, Netherlands, 3079 DZ
- Maasstad ziekenhuis
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Zeeland
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Goes, Zeeland, Netherlands, 4462 EV
- Reumazorg ZWN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Psoriatic arthritis patients treated with apremilast
Psoriatic arthritis patients who are treated with apremilast according to daily practice
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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
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The HAQ is a general questionnaire to assess physical functioning.
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Up to 24 months
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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
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PsAID is a general questionnaire that measures the health impact of psoriatic arthritis.
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Up to 24 months
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Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points
Time Frame: Up to 24 months
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The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.
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Up to 24 months
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Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6
Time Frame: Up to 6 months
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The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis.
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Up to 6 months
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Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6
Time Frame: Up to 6 months
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The DLQI is a dermatology specific Quality of Life instrument.
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Up to 6 months
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Change from Baseline in Short Form 36 (SF36) at 12 months
Time Frame: Up to 12 months
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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.
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Up to 12 months
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Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months
Time Frame: Up to 12 months
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EQ-5D is a standard instrument to measure of health status.
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Up to 12 months
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Change from Baseline in visual analogue scales (VAS) at various time point
Time Frame: Up to 24 months
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VAS is a simple assessment of the global health, itch and pain severity using a visual analogue scale
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Up to 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: MD, Amgen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC-10004-PSA-009
- CC-10004-PSA-009-20200071 (Other Identifier: Amgen)
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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