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
| Type | Name | Description |
|---|---|---|
| DRUG | Response 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.