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Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis (FAKIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00840957
First received: February 10, 2009
Last updated: October 1, 2013
Last verified: April 2010

February 10, 2009
October 1, 2013
November 2007
November 2009   (final data collection date for primary outcome measure)
Characterizing the PK and PK-PD variability of infliximab in RA [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00840957 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis
Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab

Infliximab is a chimeric monoclonal antibody directed towards Tumor Necrosis Factor -alpha that is largely used in inflammatory diseases such as rheumatoid arthritis (RA).

A relationship between dose and clinical outcomes was shown in populations of RA patients but there is an interindividual variability of this relationship. At an individual level, this dose-effet relationship can be separated into the dose-concentration (pharmacokinetic or PK) and the concentration-effet (pharmacokinetic-pharmacodynamic or PK-PD) relationships.

Serum trough concentrations of infliximab have been shown to be variable between patients receiving the same treatment regimen. This PK variability may be explained by several factors (e.g. genetic and immunological factors). The concentration-effect relationship may also be variable and the sources of this variability need to be studied as well. To date no detailed infliximab PK analysis has been published. The sources of variability of the dose-effect relationship need to be characterized to optimize infliximab dosing regimen in patients.

The FAKIR study is a multicenter prospective observational study that will focus on patients treated with infliximab. Its aims are:

  1. to characterize the PK and PK-PD variability of infliximab in RA, using clinical criteria and biomarkers, assessed over time ;
  2. to study the influence of the polymorphism of FCGRT (the gene encoding FcRn) on the PK variability of infliximab; to study the influence of the polymorphism of FCGR3A (the gene encoding Fc gamma RIIIa) on the PK-PD variability of infliximab; and to study the influence of antibodies toward infliximab on the PK and PK-PD variabilities of infliximab.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood and serum

Non-Probability Sample

Rheumatoid arthritis

Rheumatoid Arthritis
Biological: infliximab
chimeric monoclonal antibody to Tumor Necrosis Factor-alpha
A
Rhumatoid arthritis patient currently receiving infliximab
Intervention: Biological: infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00840957
PHRI07-DM / FAKIR, 2007-002752-42, 2007-R21, A70582-40
No
University Hospital, Tours
University Hospital, Tours
Not Provided
Principal Investigator: Denis MULLEMAN, MD CHRU de Tours
University Hospital, Tours
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP