- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00234234
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Basse Normandie
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Caen, Basse Normandie, France, 14
- MARCELLI
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical response
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Structural response : X-rays
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Bone response : osteodensitometry
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xavier Le Loët, MD, Pr Rheumatology, Rouen University Hospital
- Study Director: Marcelli Christian, University Hospital, Caen
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004/145/HP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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