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NCT00321217 Clinical Trial

Pharmacogenomics of Anti-TNF (Anti-tumor Necrosis Factor) Treatment in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:
Pharmacogenomics of Anti-TNF Treatment in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00321217
Other study ID # pharmacogenomics of anti-TNF
Secondary ID
Status Recruiting
Phase N/A
First received May 2, 2006
Last updated August 15, 2012
Start date May 2004
Est. completion date April 2014

Study information
Verified date November 2011
Source Radboud University
Contact M. J. Coenen, PhD
Phone 0031-24-3617649
Email m.coenen@antrg.umcn.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

The main aim of this study is to identify genetic markers (at DNA and RNA level) which are involved in the response to treatment with monoclonal antibodies against TNF in patients with rheumatoid arthritis.

Description:

Rheumatoid Arthritis (RA) is a severe inflammatory disease and genetic factors are known to play an important role in its pathogenesis. Genetic factors are also involved in determining the prognosis of RA. Identifying the genetic factors that predispose to mild or aggressive RA is not easy and up to now only a few of these factors -like certain HLA-DR species- are known.

The Rheumatology department of the Radboud University Nijmegen Medical Centre (RUNMC) has collected a unique inception cohort of over 500 patients with RA, that have been followed from an early stage of disease for up to 10 years with detailed measurements of disease activity, joint damage and other characteristics of disease progression.

In this project we use this patient group to study polymorphisms in a large battery of genes for their effect on RA disease activity/progression.

Recruitment information / eligibility
Status Recruiting
Enrollment 700
Est. completion date April 2014
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Rijnstate Arnhem
Netherlands Radboud University Nijmegen Medical Centre Nijmegen
Netherlands St Maartenskliniek Nijmegen

Sponsors (1)
Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

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