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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00321217
Collaborator
(none)
700
Enrollment
3
Locations
119
Duration (Months)
233.3
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pharmacogenomics of Anti-TNF Treatment in Patients With Rheumatoid Arthritis
    Study Start Date :
    May 1, 2004
    Anticipated Primary Completion Date :
    Nov 1, 2013
    Anticipated Study Completion Date :
    Apr 1, 2014

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.
      Exclusion Criteria:

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Rijnstate Arnhem Netherlands 6800 TA
      2 Radboud University Nijmegen Medical Centre Nijmegen Netherlands 6500 HB
      3 St Maartenskliniek Nijmegen Netherlands 6522 JV

      Sponsors and Collaborators

      • Radboud University Medical Center

      Investigators

      • Principal Investigator: M. J. Coenen, PhD, Radboud University Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Radboud University Medical Center
      ClinicalTrials.gov Identifier:
      NCT00321217
      Other Study ID Numbers:
      • pharmacogenomics of anti-TNF
      First Posted:
      May 3, 2006
      Last Update Posted:
      Aug 16, 2012
      Last Verified:
      Nov 1, 2011
      Keywords provided by Radboud University Medical Center
      rheumatoid arthritis
      pharmacogenetics
      anti-TNF
      high throughput genotyping
      Additional relevant MeSH terms:
      Arthritis
      Arthritis, Rheumatoid

      Study Results

      No Results Posted as of Aug 16, 2012