Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis (FAKIR)
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:
- to characterize the PK and PK-PD variability of infliximab in RA, using clinical criteria and biomarkers, assessed over time ;
- 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.
Studieoversikt
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Brest, Frankrike
- CHRU de Brest
-
Nantes, Frankrike
- CHRU de Nantes
-
Orléans, Frankrike
- CHR d'Orléans
-
Poitiers, Frankrike
- CHRU de Poitiers
-
Rennes, Frankrike
- CHRU de Rennes
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Tours, Frankrike
- CHRU de Tours
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
A
Rhumatoid arthritis patient currently receiving infliximab
|
chimeric monoclonal antibody to Tumor Necrosis Factor-alpha
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Characterizing the PK and PK-PD variability of infliximab in RA
Tidsramme: 6 to 12 weeks
|
6 to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: 6 to 12 weeks
|
6 to 12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Denis MULLEMAN, MD, CHRU de Tours
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PHRI07-DM / FAKIR
- 2007-002752-42 (EudraCT-nummer)
- 2007-R21 (Annen identifikator: CPP)
- A70582-40 (Annen identifikator: AFSSAPS)
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