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Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis

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Trial Information

Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)


Inclusion Criteria:



- RA according to the American College of Rheumatology (ACR) 1987 criteria

- Treatment with Adalimumab has been chosen by the physician / patient

- Treatment given in accordance to the SPC

- Stable Disease modifying anti rheumatic drugs (DMARDs) and glucocorticoids 4 weeks
before enrollment and during the study period.

- Signed consent

Exclusion Criteria:

- more than one previous treatment with anti TNF-alpha

- Past history of malignancy, AIDS

- Pregnancy

- Change in DMARDS or glucocorticoid dose 4 weeks before entering the study

- Active or latent tuberculosis, other active infections

- Surgery scheduled during the study period

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis

Outcome Description:

The primary objective is to characterize the concentration-effect relationship of adalimumab in rheumatoid arthritis (RA). To this aim, adalimumab concentration on the one hand and clinical and biological markers of disease activity on the other hand will be measured at baseline, week 4, week 8, week 12 and at week 26. Pharmacodynamic (PD) parameters will be estimated using PK(pharmacokinetic)-PD models in which Emax (maximum effect) and EC50 (concentration at which the effect is 50% of the maximum) will describe adalimumab effect on each markers of response.

Outcome Time Frame:

During the 26 weeks of follow up.

Safety Issue:

No

Principal Investigator

Denis MULLEMAN, MD, PhD

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:

PHRI10-DM/AFORA

NCT ID:

NCT01382160

Start Date:

January 2011

Completion Date:

July 2013

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid arthritis
  • adalimumab
  • pharmacokinetic-pharmacodynamic relationship
  • immunogenicity
  • Fc gamma receptors polymorphisms
  • Arthritis
  • Arthritis, Rheumatoid

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