Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Venous blood sample
Sponsored by
About this trial
This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis patients, treated with new immunosuppressive drugs : Orencia* (abatacept) and RoActemra* (tocilizumab).
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis patients
- treated with new immunosuppressive drugs : Orencia* (abatacept) and RoActemra* (tocilizumab)
- Disease longer than one year
Exclusion Criteria:
- Rheumatoid arthritis patients treated with ciclosporin in two years preceding the study
- Transplanted patients
- Disease shorter than one year
- Histories of lymphoma
Sites / Locations
- Assistance Publique-Hopitaux de Marseille
Outcomes
Primary Outcome Measures
to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab)
Secondary Outcome Measures
to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease
Full Information
NCT ID
NCT00947492
First Posted
July 27, 2009
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT00947492
Brief Title
Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs
Official Title
Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PBMNC DNA is considered a limit above which patients will develop EBV associated post transplant lymphoproliferative disorder.
we showed that methotrexate tended to decrease EBV load over time, but this did not reach significance and that TNFa inhibitors did not significantly modify EBV load over time.
Our objective is to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab), to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease.
Detailed Description
Current treatment of RA routinely includes potentially immunosuppressive medications like methotrexate and TNFa inhibitors. New immunosuppressive drugs are at disposal, Orencia* (abatacept) which is a T cell co-stimulation modulator (CTLA4Ig) and RoActemra* (tocilizumab), an antibody against IL6 receptor. In solid organ transplant recipients under immunosuppressants, emergence of lymphoma can be predicted by monitoring EBV load in peripheral blood mononuclear cells (PBMNCs). EBV load above 1000 copies per 500 ng PBMNC DNA is considered a limit above which patients will develop EBV associated post transplant lymphoproliferative disorder, a condition characterized by polyclonal EBV positive B lymphocyte proliferation which can evolve into EBV positive B cell lymphoma .
In a first study, we showed that Rheumatoid arthritis patients have 10 fold systemic EBV overload, very similar to that observed in healthy organ transplant recipients. More recently, we showed that methotrexate tended to decrease EBV load over time, but this did not reach significance and that TNFa inhibitors did not significantly modify EBV load over time.
Our objective is to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab), to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis patients, treated with new immunosuppressive drugs : Orencia* (abatacept) and RoActemra* (tocilizumab).
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Venous blood sample
Intervention Description
Venous blood sample twice a year during 3 years
Primary Outcome Measure Information:
Title
to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis patients
treated with new immunosuppressive drugs : Orencia* (abatacept) and RoActemra* (tocilizumab)
Disease longer than one year
Exclusion Criteria:
Rheumatoid arthritis patients treated with ciclosporin in two years preceding the study
Transplanted patients
Disease shorter than one year
Histories of lymphoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Balandraud
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique-Hopitaux de Marseille
City
Marseille
Country
France
12. IPD Sharing Statement
Learn more about this trial
Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs
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