Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234234
Status:
COMPLETED
Last Update Posted:
2012-02-09
First Post:
2005-10-05
Brief Title:
Predictors of the Response to Adalimumab in Rheumatoid Arthritis
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Predictors of the Response to Adalimumab in Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None