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| Sponsored by: |
Radboud University |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00321217 |
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: | Cohort, Prospective |
| Official Title: | Pharmacogenomics of Anti-TNF Treatment in Patients With Rheumatoid Arthritis |
| Estimated Enrollment: | 700 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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 |
Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: P. Barrera, PhD | 0031-24-3617649 | p.barrera@reuma.umcn.nl |
| Netherlands | |
| 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 | |
| Rijnstate | Recruiting |
| Arnhem, Netherlands, 6800 TA | |
| Contact: C. MA de Gendt, MD 0031-26-3787788 DdeGendt@alysis.nl | |
| Principal Investigator: | P. Barrera, PhD | Radboud University |
More Information
| Responsible Party: | Radboud University ( Dr. P. Barrera ) |
| Study ID Numbers: | pharmacogenomics of anti-TNF |
| Study First Received: | May 2, 2006 |
| Last Updated: | May 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00321217 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
rheumatoid arthritis pharmacogenetics anti-TNF high throughput genotyping |
|
Necrosis Autoimmune Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
|
Immune System Diseases |
