Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00213538|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 14, 2017
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.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: Response to anakinra associated with methotrexate|
|Study Type :||Observational|
|Actual Enrollment :||341 participants|
|Official Title:||Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
- Auto-antibody level [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213538
|CHU de rouen - Hôpitaux de Rouen|
|Rouen, France, 76031|
|Principal Investigator:||Xavier Le Loët||Rouen University Hospital|