Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis
The objective of the study is to identify and validate predictive markers of anakinra responsiveness in RA patients by a transcriptomic approach.
Patients with active RA (ACR criteria) were given subcutaneous anakinra (100mg/d) 3 associated with metotrexate. Anakinra efficacy was evaluated at week 12, using the EULAR response criteria.
A blood sample was collected just before the onset of anakinra treatment and total RNAs were extracted from the peripheral blood mononuclear cells. 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.
Drug: Response to anakinra associated with methotrexate
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis|
- Auto-antibody level [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213538
|CHU de rouen - Hôpitaux de Rouen|
|Rouen, France, 76031|
|Principal Investigator:||Xavier Le Loët||Rouen University Hospital|