NCT00321217

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2004

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 16, 2012

Status Verified

November 1, 2011

Enrollment Period

9.5 years

First QC Date

May 2, 2006

Last Update Submit

August 15, 2012

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritispharmacogeneticsanti-TNFhigh throughput genotyping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rijnstate

Arnhem, 6800 TA, Netherlands

RECRUITING

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

RECRUITING

St Maartenskliniek

Nijmegen, 6522 JV, Netherlands

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • M. J. Coenen, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M. J. Coenen, PhD

CONTACT

0031-24-3617649m.coenen@antrg.umcn.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 3, 2006

Study Start

May 1, 2004

Primary Completion

November 1, 2013

Study Completion

April 1, 2014

Last Updated

August 16, 2012

Record last verified: 2011-11

Locations

NL(3)