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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00321217
First received: May 2, 2006
Last updated: August 15, 2012
Last verified: November 2011
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomics of Anti-TNF Treatment in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 700
Study Start Date: May 2004
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321217

Contacts
Contact: M. J. Coenen, PhD 0031-24-3617649 m.coenen@antrg.umcn.nl

Locations
Netherlands
Rijnstate Recruiting
Arnhem, Netherlands, 6800 TA
Contact: C. MA de Gendt, MD    0031-26-3787788    DdeGendt@alysis.nl   
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: P. Barrera, PhD    0031-24-3617649    p.barrera@reuma.umcn.nl   
St Maartenskliniek Recruiting
Nijmegen, Netherlands, 6522 JV
Contact: D. JR de Rooij, PhD    0031-24-3659280    D.derooij@maartenskliniek.nl   
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: M. J. Coenen, PhD Radboud University
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00321217     History of Changes
Other Study ID Numbers: pharmacogenomics of anti-TNF
Study First Received: May 2, 2006
Last Updated: August 15, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
rheumatoid arthritis
pharmacogenetics
anti-TNF
high throughput genotyping

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014