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Predictors of the Response to Adalimumab in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Biologics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • MARCELLI

Outcomes

Primary Outcome Measures

Clinical response
Structural response : X-rays
Bone response : osteodensitometry

Secondary Outcome Measures

Full Information

First Posted
October 5, 2005
Last Updated
February 8, 2012
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT00234234
Brief Title
Predictors of the Response to Adalimumab in Rheumatoid Arthritis
Official Title
Predictors of the Response to Adalimumab in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Biologics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adalimumab
Primary Outcome Measure Information:
Title
Clinical response
Title
Structural response : X-rays
Title
Bone response : osteodensitometry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Le Loët, MD, Pr Rheumatology
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcelli Christian
Organizational Affiliation
University Hospital, Caen
Official's Role
Study Director
Facility Information:
Facility Name
MARCELLI
City
Caen
State/Province
Basse Normandie
ZIP/Postal Code
14
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35313956
Citation
Vittecoq O, Guillou C, Hardouin J, Gerard B, Berenbaum F, Constantin A, Rincheval N, Combe B, Lequerre T, Cosette P. Validation in the ESPOIR cohort of vitamin K-dependent protein S (PROS) as a potential biomarker capable of predicting response to the methotrexate/etanercept combination. Arthritis Res Ther. 2022 Mar 21;24(1):72. doi: 10.1186/s13075-022-02762-5.
Results Reference
derived
PubMed Identifier
26714738
Citation
Golinski ML, Vandhuick T, Derambure C, Freret M, Lecuyer M, Guillou C, Hiron M, Boyer O, Le Loet X, Vittecoq O, Lequerre T. Dysregulation of RasGRP1 in rheumatoid arthritis and modulation of RasGRP3 as a biomarker of TNFalpha inhibitors. Arthritis Res Ther. 2015 Dec 26;17:382. doi: 10.1186/s13075-015-0894-9.
Results Reference
derived
PubMed Identifier
25223394
Citation
Ternant D, Ducourau E, Fuzibet P, Vignault C, Watier H, Lequerre T, Le Loet X, Vittecoq O, Goupille P, Mulleman D, Paintaud G. Pharmacokinetics and concentration-effect relationship of adalimumab in rheumatoid arthritis. Br J Clin Pharmacol. 2015 Feb;79(2):286-97. doi: 10.1111/bcp.12509.
Results Reference
derived
PubMed Identifier
21791546
Citation
Blache C, Lequerre T, Roucheux A, Beutheu S, Dedreux I, Jacquot S, Le Loet 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. doi: 10.1093/rheumatology/ker183. Epub 2011 Jul 26.
Results Reference
derived

Learn more about this trial

Predictors of the Response to Adalimumab in Rheumatoid Arthritis

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