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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02322580
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : December 2, 2016
Information provided by (Responsible Party):
Universitaire Ziekenhuizen 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.

Condition or disease Intervention/treatment
Psoriasis Drug: etanercept

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intermittent Versus Continuous Treatment: an Observational Monocentric Study Investigating the Association Between Trough Levels of Enbrel and Therapy Regimen
Study Start Date : January 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept

Group/Cohort Intervention/treatment
Psoriasis patients who receive Enbrel® therapy Drug: etanercept
Other Name: Enbrel®

Primary Outcome Measures :
  1. trough serum etanercept concentration [ Time Frame: one year ]
  2. anti-etanercept serum concentration [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Psoriasis patients who receive Enbrel® therapy according to the current EU Summary of Product Characteristics (SmPC)

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
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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT02322580    
Other Study ID Numbers: S56818
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: May 2016
Keywords provided by Universitaire Ziekenhuizen Leuven:
therapeutic drug monitoring
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors