NCT00947492

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

5.3 years

First QC Date

July 27, 2009

Last Update Submit

August 27, 2014

Conditions

Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (1)

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

    3 years

Interventions

Venous blood sampleBIOLOGICAL

Venous blood sample twice a year during 3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis patients
  • treated with new immunosuppressive drugs : Orencia\* (abatacept) and RoActemra\* (tocilizumab)
  • Disease longer than one year

You may not qualify if:

  • Rheumatoid arthritis patients treated with ciclosporin in two years preceding the study
  • Transplanted patients
  • Disease shorter than one year
  • Histories of lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique-Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nathalie Balandraud

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 28, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

FR(1)