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

NCT ID: NCT00321217

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Keywords

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rheumatoid arthritis pharmacogenetics anti-TNF high throughput genotyping

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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M. J. Coenen, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Rijnstate

Arnhem, , Netherlands

Site Status RECRUITING

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status RECRUITING

St Maartenskliniek

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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M. J. Coenen, PhD

Role: CONTACT

Phone: 0031-24-3617649

Email: [email protected]

Facility Contacts

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C. MA de Gendt, MD

Role: primary

P. Barrera, PhD

Role: primary

D. JR de Rooij, PhD

Role: primary

Other Identifiers

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pharmacogenomics of anti-TNF

Identifier Type: -

Identifier Source: org_study_id