NCT00840957

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. 1.to characterize the PK and PK-PD variability of infliximab in RA, using clinical criteria and biomarkers, assessed over time ;
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

February 10, 2009

Last Update Submit

April 8, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Characterizing the PK and PK-PD variability of infliximab in RA

    6 to 12 weeks

Secondary Outcomes (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

    6 to 12 weeks

Study Arms (1)

A

Rhumatoid arthritis patient currently receiving infliximab

Biological: infliximab

Interventions

infliximabBIOLOGICAL

chimeric monoclonal antibody to Tumor Necrosis Factor-alpha

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatoid arthritis

You may qualify if:

  • 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

You may not qualify if:

  • Surgery scheduled during the duration of the study
  • Pregnancy
  • infection, malignancy, immune reaction to infliximab or demyelinating diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHRU de Brest

Brest, France

Location

CHRU de Nantes

Nantes, France

Location

CHR d'Orléans

Orléans, France

Location

CHRU de Poitiers

Poitiers, France

Location

CHRU de Rennes

Rennes, France

Location

CHRU de Tours

Tours, France

Location

Related Publications (1)

  • Ternant D, Ducourau E, Perdriger A, Corondan A, Le Goff B, Devauchelle-Pensec V, Solau-Gervais E, Watier H, Goupille P, Paintaud G, Mulleman D. Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis. Br J Clin Pharmacol. 2014 Jul;78(1):118-28. doi: 10.1111/bcp.12313.

    PMID: 24354889RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and serum

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Denis MULLEMAN, MD

    CHRU de Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

November 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

FR(6)