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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00213564
Date of registration: 13/09/2005
Prospective Registration: No
Primary sponsor: University Hospital, Rouen
Public title: Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis
Scientific title: Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis
Date of first enrolment: April 2003
Target sample size: 40
Recruitment status: Completed
Study type:  Observational
Study design:  Time Perspective: Prospective  
Countries of recruitment
Name:     Xavier Le Lo√ęt
Affiliation:  Rouen university Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- Is age 18 years old or older Satisfies the 1987 American College of Rheumatology
revised criteria for Rheumatoid arthritis Has active disease at the time of
randomization as indicated by a DAS28> 5.1 Has a disease at least refractory to
DMARDs whose methotrexate or leflunomide Is capable of understanding and signing an
informed consent form Agrees to use a medically accepted form of contraception during
the study

Exclusion Criteria:

- Is pregnant or breast-feeding or without Has significant concurrent medical diseases
including cancer or a history of cancer within 5 years of entering the study,
uncompensated congestive heart failure, significant active infection or any
underlying diseases that could predispose subjects to infections (whose tuberculosis)
Has allergy to infliximab

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: response to infliximab associated with methotrexate
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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