Status:

COMPLETED

Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice

Lead Sponsor:

Pfizer

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Brief Summary

Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept

Detailed Description

The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 5 independent variables as CDAI, SDAI, DAS28, DAS28 and...

Eligibility Criteria

Inclusion

  • Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the SmPC.
  • First cohort: Etanercept is the first biological product prescribed.
  • Second cohort: Etanercept is the second biological product prescribed.
  • Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
  • Eighteen (18) years of age or older at time of consent.

Exclusion

  • 1\. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.

Key Trial Info

Start Date :

August 12 2014

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 24 2017

Estimated Enrollment :

157 Patients enrolled

Trial Details

Trial ID

NCT02202837

Start Date

August 12 2014

End Date

April 24 2017

Last Update

December 3 2018

Active Locations (35)

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Page 1 of 9 (35 locations)

1

CHU Dinant Godinne

Yvoir, Namur, Belgium, 5530

2

ASZ Aalst

Aalst, Belgium, 9300

3

Algemeen Stedelijk Ziekenhuis

Aalst, Belgium, B-9300

4

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, Belgium, B-9300