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

Study Purpose

This is a multicenter, prospective, non-interventional, observational single arm study. Two-hundred 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02875184
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Psoriatic
Study Website: View Trial Website
Additional Details

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).

Arms & Interventions

Arms

: Psoriatic arthritis patients treated with apremilast

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Reumazorg ZWN, Lelystad/Emmeloord, Flevoland, Netherlands

Status

Recruiting

Address

Reumazorg ZWN

Lelystad/Emmeloord, Flevoland, 8233GT / 8303 BX

MC Leeuwarden, Leeuwarden, Friesland, Netherlands

Status

Recruiting

Address

MC Leeuwarden

Leeuwarden, Friesland, 8934 AD

St. Jansdal, Harderwijk, Gelderland, Netherlands

Status

Recruiting

Address

St. Jansdal

Harderwijk, Gelderland, 3844DG

Viecuri Medisch Centrum, Venlo, Limburg, Netherlands

Status

Recruiting

Address

Viecuri Medisch Centrum

Venlo, Limburg, 5912 BL

Reumazorg ZWN, Roosendaal, Noord-Brabant, Netherlands

Status

Recruiting

Address

Reumazorg ZWN

Roosendaal, Noord-Brabant, 4707 CH

Amphia, Breda, North-Brabant, Netherlands

Status

Recruiting

Address

Amphia

Breda, North-Brabant, 4819 EV

Elkerliek ziekenhuis, Helmond, North-Brabant, Netherlands

Status

Completed

Address

Elkerliek ziekenhuis

Helmond, North-Brabant, 5707 HA

Beatrix Ziekenhuis, Gorinchem, South-Holland, Netherlands

Status

Recruiting

Address

Beatrix Ziekenhuis

Gorinchem, South-Holland, 4204 AA

Groene Hart Ziekenhuis, Gouda, South-Holland, Netherlands

Status

Recruiting

Address

Groene Hart Ziekenhuis

Gouda, South-Holland, 2803 HH

Erasmus MC, Rotterdam, South-Holland, Netherlands

Status

Recruiting

Address

Erasmus MC

Rotterdam, South-Holland, 3015 CE

Maasstad Ziekenhuis, Rotterdam, South-Holland, Netherlands

Status

Recruiting

Address

Maasstad Ziekenhuis

Rotterdam, South-Holland, 3079 DZ

Reumazorg ZWN, Goes, Zeeland, Netherlands

Status

Recruiting

Address

Reumazorg ZWN

Goes, Zeeland, 4462 EV

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