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Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis (FAKIR)

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ClinicalTrials.gov Identifier: NCT00840957
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Biological: infliximab

Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab
Study Start Date : November 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Group/Cohort Intervention/treatment
A
Rhumatoid arthritis patient currently receiving infliximab
Biological: infliximab
chimeric monoclonal antibody to Tumor Necrosis Factor-alpha



Primary Outcome Measures :
  1. Characterizing the PK and PK-PD variability of infliximab in RA [ Time Frame: 6 to 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
whole blood and serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid arthritis
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

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): NCT00840957


Locations
France
CHRU de Brest
Brest, France
CHRU de Nantes
Nantes, France
CHR d'Orléans
Orléans, France
CHRU de Poitiers
Poitiers, France
CHRU de Rennes
Rennes, France
CHRU de Tours
Tours, France
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Denis MULLEMAN, MD CHRU de Tours

Publications of Results:
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00840957     History of Changes
Other Study ID Numbers: PHRI07-DM / FAKIR
2007-002752-42 ( EudraCT Number )
2007-R21 ( Other Identifier: CPP )
A70582-40 ( Other Identifier: AFSSAPS )
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents