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Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs

Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00947492
Enrollment
60
Registered
2009-07-28
Start date
2009-06-30
Completion date
2014-12-31
Last updated
2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis patients, treated with new immunosuppressive drugs : Orencia* (abatacept) and RoActemra* (tocilizumab).

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.

Interventions

Venous blood sample twice a year during 3 years

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab)3 years

Secondary

MeasureTime frame
to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026