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

Completed

• Conditions: Psoriasis
• Interventions: Drug: etanercept

• Registration Number: NCT02322580
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Study Start: 2015-01
• Status Verified: 2016-05
• Primary Completion: 2016-09
• Study Completion: 2016-11
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psoriasis patients who receive Enbrel® therapy	etanercept	-

Primary Outcome Measures

Name	Time	Method
trough serum etanercept concentration	one year
anti-etanercept serum concentration	one year