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

NCT ID: NCT02875184

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-06

Study Completion Date

2022-06-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Arthritis, Psoriatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Psoriatic arthritis patients treated with apremilast

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Reumazorg ZWN

Lelystad/Emmeloord, Flevoland, Netherlands

Site Status

St. Jansdal

Harderwijk, Gelderland, Netherlands

Site Status

Viecuri Medisch Centrum

Venlo, Limburg, Netherlands

Site Status

Amphia

Breda, North Brabant, Netherlands

Site Status

Elkerliek ziekenhuis

Helmond, North Brabant, Netherlands

Site Status

Reumazorg ZWN

Roosendaal, North Brabant, Netherlands

Site Status

MC Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Site Status

Beatrix Ziekenhuis

Gorinchem, South Holland, Netherlands

Site Status

Groene Hart Ziekenhuis

Gouda, South Holland, Netherlands

Site Status

Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Site Status

Reumazorg ZWN

Goes, Zeeland, Netherlands

Site Status

Research Site

Breda, , Netherlands

Site Status

Research Site

Gorinchem, , Netherlands

Site Status

Research Site

Gouda, , Netherlands

Site Status

Research Site

Harderwijk, , Netherlands

Site Status

Research Site

Leeuwarden, , Netherlands

Site Status

Research Site

Roosendaal, , Netherlands

Site Status

Research Site

Rotterdam, , Netherlands

Site Status

Research Site

Rotterdam, , Netherlands

Site Status

Research Site

Venlo, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

https://clinicaltrials.gov/ct2/show/NCT02875184?term=CC-10004-PSA-009&rank=1

Expanded Access for CC-100004

Other Identifiers

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CC-10004-PSA-009-20200071

Identifier Type: OTHER

Identifier Source: secondary_id

CC-10004-PSA-009

Identifier Type: -

Identifier Source: org_study_id

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