Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis |
Biological: Venous blood sample |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab). |
- to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
-
Biological: Venous blood sample
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Nathalie Balandraud | nathalie.balandraud@ap-hm.fr |
| France | |
| Assistance Publique-Hopitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Nathalie Balandraud nathalie.balandraud@ap-hm.fr | |
| Principal Investigator: Nathalie Balandraud | |
| Principal Investigator: | Nathalie Balandraud | Assistance Publique Hopitaux De Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille, Direction de la Recherche |
| ClinicalTrials.gov Identifier: | NCT00947492 History of Changes |
| Other Study ID Numbers: | 2009-07, 2009-A00247-50 |
| Study First Received: | July 27, 2009 |
| Last Updated: | October 19, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
Rheumatoid Arthritis patients treated with new immunosuppressive drugs : Orencia* (abatacept) and RoActemra* (tocilizumab). |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013