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Predictors of the Response to Adalimumab in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00234234
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Adalimumab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predictors of the Response to Adalimumab in Rheumatoid Arthritis
Study Start Date : January 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Primary Outcome Measures :
  1. Clinical response
  2. Structural response : X-rays
  3. Bone response : osteodensitometry

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234234

Caen, Basse Normandie, France, 14
Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Xavier Le Loët, MD, Pr Rheumatology Rouen University Hospital
Study Director: Marcelli Christian University Hospital, Caen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00234234     History of Changes
Other Study ID Numbers: 2004/145/HP
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

Keywords provided by University Hospital, Rouen:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Antirheumatic Agents