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

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ClinicalTrials.gov Identifier: NCT00947492
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Active, not recruiting
First Posted : July 28, 2009
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Venous blood sample Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).
Study Start Date : June 2009
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept


Intervention Details:
  • Biological: Venous blood sample
    Venous blood sample twice a year during 3 years


Primary Outcome Measures :
  1. 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 Measures :
  1. to detect possible immunosuppression associated EBV dysregulation, as seen in post transplant lymphoproliferative disease [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947492


Locations
France
Assistance Publique-Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Nathalie Balandraud Assistance Publique Hopitaux De Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00947492     History of Changes
Other Study ID Numbers: 2009-07
2009-A00247-50
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014

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
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents