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Clinical Trials/NCT00947492
NCT00947492UnknownNot Applicable

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

Assistance Publique Hopitaux De Marseille1 site in 1 country60 target enrollmentStarted: June 1, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
to monitor Epstein Barr Virus load over time in patients with Rheumatoid arthritis under Orencia* (abatacept) or RoActemra* (tocilizumab)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
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

Outcomes

Primary Outcomes

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

Time Frame: 3 years

Secondary Outcomes

  • to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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