NCT02322580

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 2, 2016

Status Verified

May 1, 2016

Enrollment Period

1.7 years

First QC Date

December 11, 2014

Last Update Submit

December 1, 2016

Conditions

Psoriasis

Keywords

anti-TNFtherapeutic drug monitoringimmunogenicity

Outcome Measures

Primary Outcomes (2)

  • trough serum etanercept concentration

    one year

  • anti-etanercept serum concentration

    one year

Study Arms (1)

Psoriasis patients who receive Enbrel® therapy

Drug: etanercept

Interventions

etanerceptDRUG
Also known as: Enbrel®
Psoriasis patients who receive Enbrel® therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Psoriasis patients who receive Enbrel® therapy according to the current EU Summary of Product Characteristics (SmPC)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 23, 2014

Study Start

January 1, 2015

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

December 2, 2016

Record last verified: 2016-05