Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213564
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2005-09-13
Brief Title:
Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 iv 3 mgkg 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
1 Just before the starting of infliximab treatment the following parameters were measured in the sera i immunological tests rheumatoid factor IgA IgG IgM anti-CCP autoAb recognizing the 27 C-terminal fragment ACAST-C27 and domain I ACAST-DI of calpastatin anti-G6PI anti a-enolase anti-keratin and anti-perinuclear factor ii biochemical markers CRP MMP-1 MMP-3 TIMP-1 TIMP-2 markers of bone resorption pyridinolin deoxypyridinolin osteoprotegerin sRANKL COMP The predictive value of each parameter for a responsenon-response to infliximab was analysed using Fischers exact Mann-Whitney and Chi2 tests
2 A blood sample was collected just before the onset of infliximab 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 10000 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
Patients with active RA ACR criteria were given iv 3 mgkg 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
1 Just before the starting of infliximab treatment the following parameters were measured in the sera i immunological tests rheumatoid factor IgA IgG IgM anti-CCP autoAb recognizing the 27 C-terminal fragment ACAST-C27 and domain I ACAST-DI of calpastatin anti-G6PI anti a-enolase anti-keratin and anti-perinuclear factor ii biochemical markers CRP MMP-1 MMP-3 TIMP-1 TIMP-2 markers of bone resorption pyridinolin deoxypyridinolin osteoprotegerin sRANKL COMP The predictive value of each parameter for a responsenon-response to infliximab was analysed using Fischers exact Mann-Whitney and Chi2 tests
2 A blood sample was collected just before the onset of infliximab 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 10000 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None