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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.
Register: ClinicalTrials.gov
Last refreshed on: 20 April 2015
Main ID:  NCT00840957
Date of registration: 10/02/2009
Prospective Registration: No
Primary sponsor: University Hospital, Tours
Public title: Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis FAKIR
Scientific title: Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab
Date of first enrolment: November 2007
Target sample size: 84
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00840957
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Denis MULLEMAN, MD
Address: 
Telephone:
Email:
Affiliation:  CHRU de Tours
Key inclusion & exclusion criteria

Inclusion Criteria:

- Rheumatoid arthritis according to ACR criteria

- Patient already receiving infliximab for more than 14 weeks

- No modification of the dose regimen of infliximab since the last infusion

- No modification of disease modifying anti rheumatic drugs since the last 4 weeks

Exclusion Criteria:

- Surgery scheduled during the duration of the study

- Pregnancy

- infection, malignancy, immune reaction to infliximab or demyelinating diseases



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: infliximab
Primary Outcome(s)
Characterizing the PK and PK-PD variability of infliximab in RA [Time Frame: 6 to 12 weeks]
Secondary Outcome(s)
Studying the relation between FCGRT polymorphism and the PK variability of infliximab; the relation between FCGR3A polymorphism and the PK-PD variability of infliximab; and the relation between ATI and the PK and PK-PD variabilities of infliximab [Time Frame: 6 to 12 weeks]
Secondary ID(s)
2007-002752-42
2007-R21
A70582-40
PHRI07-DM / FAKIR
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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