Trial Information
Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Characterizing the PK and PK-PD variability of infliximab in RA
Outcome Time Frame:
6 to 12 weeks
Safety Issue:
No
Principal Investigator
Denis MULLEMAN, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
CHRU de Tours
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
PHRI07-DM / FAKIR
NCT ID:
NCT00840957
Start Date:
November 2007
Completion Date:
November 2009
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid