Rheumatoid ArthritisNCT00321217
Pharmacogenomics of Anti-TNF (Anti-tumor Necrosis Factor) Treatment in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 700 participants
- Where
- 3 sitesNetherlands
- Study dates
- May 2004to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.
Who may be able to join
- Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Rijnstate
Arnhem, 6800 TA
C. MA de Gendt, MD, 0031-26-3787788, DdeGendt@alysis.nl
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
P. Barrera, PhD, 0031-24-3617649, p.barrera@reuma.umcn.nl
- Recruiting
St Maartenskliniek
Nijmegen, 6522 JV
D. JR de Rooij, PhD, 0031-24-3659280, D.derooij@maartenskliniek.nl
About this study
Official title: Pharmacogenomics of Anti-TNF Treatment in Patients With Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, pharmacogenetics, anti-TNF, high throughput genotyping
- Medical subject headings
- Arthritis, Rheumatoid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMay 2004
- Primary completionNov 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. J. Coenen, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321217
- Sponsor's protocol ID
- pharmacogenomics of anti-TNF
- Status last verified
- Nov 2011
- First submitted
- 2 May 2006
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of Anti-TNF Treatment in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00321217
- Acronym / sponsor ID
- pharmacogenomics of anti-TNF
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, pharmacogenetics, anti-TNF, high throughput genotyping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.
Key inclusion criteria (1 listed)
- Patients with RA according to the ACR criteria who are treated with monoclonal anti-TNF antibodies.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. J. Coenen, PhD principal investigator
Radboud University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Radboud University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M. J. Coenen, PhD (0031-24-3617649, m.coenen@antrg.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.