Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis (FAKIR)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Biological: infliximab

Study type: Observational

Funder types: Other

Identifiers

NCT00840957

2007-R21 (Other Identifier)

A70582-40 (Other Identifier)

2007-002752-42 (EudraCT Number)

PHRI07-DM / FAKIR

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

84 participants in 1 patient group

A

Description:

Rhumatoid arthritis patient currently receiving infliximab

Treatment:

Biological: infliximab