Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02304354
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2014-11-04
Brief Title:
Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis LYRITUX
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis LYRITUX
Status:
COMPLETED
Status Verified Date:
2021-05
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:
LYRITUX
Brief Summary:
Rituximab an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in rheumatoid arthritis RA patients refractory to TNF alpha antagonists According to previous studies 25 to 50 of patients have an insufficient or absence of response to rituximab at week 24
In a recent retrospective study a CD4 T-lymphocytes depletion was observed after a first course of rituximab in RA patients The absolute CD4 number at week 12 was 37 33 of the baseline value leading to 200 cellsµL in 5 of patients Interestingly the absence of CD4 T-lymphocytes depletion was observed in clinical non-responders suggesting the involvement of T-lymphocytes in the mechanism of action of rituximab So far no prospective study have supported the usefulness of lymphocyte phenotyping in particular T-lymphocytes to monitor rituximab-treated RA patients
In a recent retrospective study a CD4 T-lymphocytes depletion was observed after a first course of rituximab in RA patients The absolute CD4 number at week 12 was 37 33 of the baseline value leading to 200 cellsµL in 5 of patients Interestingly the absence of CD4 T-lymphocytes depletion was observed in clinical non-responders suggesting the involvement of T-lymphocytes in the mechanism of action of rituximab So far no prospective study have supported the usefulness of lymphocyte phenotyping in particular T-lymphocytes to monitor rituximab-treated RA patients
Detailed Description:
Rituximab an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in rheumatoid arthritis RA patients refractory to TNF alpha antagonists According to previous studies Edwards Szczepanski et al 2004 Cohen Emery et al 2006 Emery Fleischmann et al 2006 25 to 50 of patients have an insufficient or absence of response to rituximab at week 24 In the pathogenesis of RA B and T lymphocytes are tightly linked through the APC fonction and cytokines production of B lymphocytes At present a white blood cells count is recommended in routine every 3 months in patients receiving rituximab since cases of neutropenia have been observed in approximately 8 of patients with lymphoma after treatment In RA patients B lymphocytes count before each rituximab course should be done to prevent opportunistic infections Pham Fautrel et al 2008
In a recent retrospective study a CD4 T-lymphocytes depletion was observed after a first course of rituximab in RA patients The absolute CD4 number at week 12 was 37 33 of the baseline value leading to 200 cellsµL in 5 of patients Interestingly the absence of CD4 T-lymphocytes depletion was observed in clinical non-responders suggesting the involvement of T-lymphocytes in the mechanism of action of rituximab Mélet Mulleman et al 2013 Moreover few case reports of RA patients developing opportunist infections in conjunction with CD4 T-lymphocyte depletion have been published Teichmann Woenckhaus et al 2008 Clifford Ances et al 2011 So far no prospective study have supported the usefulness of lymphocyte phenotyping in particular T-lymphocytes to monitor rituximab-treated RA patients
In a recent retrospective study a CD4 T-lymphocytes depletion was observed after a first course of rituximab in RA patients The absolute CD4 number at week 12 was 37 33 of the baseline value leading to 200 cellsµL in 5 of patients Interestingly the absence of CD4 T-lymphocytes depletion was observed in clinical non-responders suggesting the involvement of T-lymphocytes in the mechanism of action of rituximab Mélet Mulleman et al 2013 Moreover few case reports of RA patients developing opportunist infections in conjunction with CD4 T-lymphocyte depletion have been published Teichmann Woenckhaus et al 2008 Clifford Ances et al 2011 So far no prospective study have supported the usefulness of lymphocyte phenotyping in particular T-lymphocytes to monitor rituximab-treated RA patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 140896A-32 | OTHER | ANSM | None |
| 2014-000859-91 | EUDRACT_NUMBER | None | None |
| 2014-R24 | OTHER | None | None |