Rheumatoid Arthritis Clinical Trial
Official title:
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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