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Trial record 1 of 1 for:    NCT02322580
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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)

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ClinicalTrials.gov Identifier: NCT02322580
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : December 2, 2016
Sponsor:
Collaborator:
Pfizer
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)
Criteria

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
ClinicalTrials.gov 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:
anti-TNF
therapeutic drug monitoring
immunogenicity
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors