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Sponsored by: |
University Hospital, Rouen |
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Information provided by: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00213564 |
The objective of the study is to identify and validate predictive markers of infliximab responsiveness in RA patients by 2 approaches: i) measuring biochemical, immunological and bone markers in sera because of their involvement in pathogenic mechanisms; ii) identifying gene-expression signatures in PBMCs by the transcriptomic analysis. Patients with active RA (ACR criteria) were given i.v. 3 mg/kg infliximab associated with metotrexate at weeks 0, 2, 6, and every 8th week. Infliximab efficacy was evaluated at week 14, using the EULAR response criteria.
The [33P] radiolabeled mRNAs were hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a high density on nylon membranes. Data were normalized and filtered to allow the comparison between RNA samples. Statistical analyses were performed with the R software and hierarchical clustering was performed with the Cluster and Tree View softwares.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: response to infliximab associated with methotrexate |
Phase IV |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
CHU de Rouen - Hôpitaux de Rouen | Recruiting |
ROUEN, France, 76031 | |
Contact: Xavier Le Loët, MD 33 2 32 88 90 19 xavier.le-loet@chu-rouen.fr | |
Sub-Investigator: Jean-philippe Salier, PhD | |
Sub-Investigator: Maryvonne Daveau, MDPhD | |
Sub-Investigator: Thierry Lequerré, MD | |
Sub-Investigator: François Tron, MDPhD | |
Sub-Investigator: Olivier Vittecoq, MDPhD | |
Sub-Investigator: Alain Daragon, MD | |
Sub-Investigator: Othmane Mejjad, MD |
Principal Investigator: | Xavier Le Loët | Rouen university Hospital |
Study ID Numbers: | 2002/061/HP |
Study First Received: | September 13, 2005 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00213564 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Anti-Inflammatory Agents Antimetabolites Autoimmune Diseases Immunologic Factors Infliximab Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Folic Acid Antagonists Immunosuppressive Agents Folic Acid Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Infliximab Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Gastrointestinal Agents Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |