Clinical Trials Directory

Trials / Completed

CompletedNCT00213538

Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

Status
Completed
Phase
Study type
Observational
Enrollment
341 (actual)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGResponse to anakinra associated with methotrexate

Timeline

Start date
2003-06-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2005-09-21
Last updated
2017-06-14

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00213538. Inclusion in this directory is not an endorsement.