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Predictors of the Response to Adalimumab in Rheumatoid Arthritis

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: October 5, 2005
Last updated: February 8, 2012
Last verified: February 2012

October 5, 2005
February 8, 2012
January 2006
December 2008   (final data collection date for primary outcome measure)
  • Clinical response
  • Structural response : X-rays
  • Bone response : osteodensitometry
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Complete list of historical versions of study NCT00234234 on Archive Site
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Predictors of the Response to Adalimumab in Rheumatoid Arthritis
Predictors of the Response to Adalimumab in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease which is characterized by joint inflammation (clinical involvement), by osteo-cartilaginous lesions (structural damage) and generally by bone involvement. All those features lead to great disability. Because it represents a major problem of the public health care system, RA has been selected as one of the main objectives of the government for the next five years.

RA patients who do not respond to DMARDs require a treatment by TNF-a blocking agents. However, no information is available to predict the clinical, structural and bone responses to those new drugs that can be responsible of severe side-effects. Moreover, they are particularly expensive since their yearly cost is estimated between 75000 and 112500 k euros for the G4 region.

The purpose of the present research project is to determine potential predictive factors of the response to a new TNF-a blocker ie adalimumab. To address this question, several investigations will be performed including measurement of different blood markers, particularly bone markers, well-defined autoantibodies and new autoantibody populations identified by proteomic analysis, large-scale analysis of gene expression with cDNA arrays from blood mononuclear cells, and use of different imaging tools.

The criteria of judgement will be the clinical, structural and bone responses to those new agents.

This study requires the recruitment of about 100 patients receiving adalimumab for a 1-year period.

At the end of the study, we hope to identify predictive factors of the response to adalimumab, which will lead to a better management of this TNF-a blocker. Indeed, they will be prescribed only for the patients who are likely to respond to those drugs. Thus, this study should allow to elaborate theranostic algorithms. Such an approach will have great benefits for the patients: more rapid efficacy, less severe side-reactions and lower costs.

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Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Adalimumab
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Blache C, Lequerré T, Roucheux A, Beutheu S, Dedreux I, Jacquot S, Le Loët X, Boyer O, Vittecoq O. Number and phenotype of rheumatoid arthritis patients' CD4+CD25hi regulatory T cells are not affected by adalimumab or etanercept. Rheumatology (Oxford). 2011 Oct;50(10):1814-22. Epub 2011 Jul 26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ACR classification criteria of RA
  • DAS 28 > 5.1
  • inadequately controlled by at least one DMARD
  • biologics naïve

Exclusion Criteria:

  • exclusion criteria of adalimumab and methotrexate (regulation authorities)
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
University Hospital, Rouen
University Hospital, Rouen
Not Provided
Principal Investigator: Xavier Le Loët, MD, Pr Rheumatology Rouen University Hospital
Study Director: Marcelli Christian University Hospital, Caen
University Hospital, Rouen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP