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NCT02322580 Clinical Trial

An Observational Monocentric Study Investigating the Association Between Trough Serum Levels of Etanercept, Antibodies Towards Etanercept and Its Effectiveness in Psoriasis Patients

Psoriasis Clinical Trial

— DERM  

Official title:
Intermittent Versus Continuous Treatment: an Observational Monocentric Study Investigating the Association Between Trough Levels of Enbrel and Therapy Regimen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02322580
Other study ID # S56818
Secondary ID
Status Completed
Phase N/A
First received December 11, 2014
Last updated December 1, 2016
Start date January 2015
Est. completion date November 2016

Study information
Verified date May 2016
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date November 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age from 18 years on, male or female

- Established diagnosis of psoriasis

- Etanercept either on monotherapy or in combination with acitretin (Neotigason®), given according to the current EU SmPC including the safety measures.

- Patients who give informed consent for this study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• etanercept

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary trough serum etanercept concentration one year No
Primary anti-etanercept serum concentration one year No
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