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Predictors of the Response to Adalimumab in Rheumatoid Arthritis
This study is currently recruiting participants.
Verified by University Hospital, Rouen, May 2007
Sponsored by: University Hospital, Rouen
Information provided by: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00234234
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Adalimumab
Phase IV

MedlinePlus related topics: Rheumatoid Arthritis
Drug Information available for: Adalimumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Predictors of the Response to Adalimumab in Rheumatoid Arthritis

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Clinical response
  • Structural response : X-rays
  • Bone response : osteodensitometry

Estimated Enrollment: 200
Study Start Date: January 2006
Estimated Study Completion Date: June 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234234

Contacts
Contact: Xavier Le Loët, MD, Pr rheumatology 33 2 32 88 90 19 xavier.le-loet@chu-rouen.fr
Contact: Olivier Vittecoq, MD, Ph D, Pr rheumatology 33 2 32 88 90 19 olivier.vittecoq@chu-rouen.fr

Locations
France, Basse Normandie
MARCELLI Recruiting
CAEN, Basse Normandie, France, 14
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Xavier Le Loët, MD, Pr Rheumatology Rouen University Hospital
Study Director: Marcelli Christian CHU de Caen
  More Information

Study ID Numbers: 2004/145/HP
Study First Received: October 5, 2005
Last Updated: May 14, 2007
ClinicalTrials.gov Identifier: NCT00234234  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:
Biologics

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009