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Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab


N/A
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

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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

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