drugset / Trial / NCT01400464

Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis

NCT01400464

Phase 4 Unknown 150 enrolled University Hospital, Caen
NaSingle-groupOpen-labelTreatment

Summary

The factors underlying the large interindividual variability in response to glucocorticoids in Giant Cell Arteritis are poorly understood. The investigators hypothesize that a part of this variability is related to pharmacokinetic factors determined by genetic polymorphism: hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1). The investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic cohort study to assess the link between prednisolone clearance and the relapse risk in giant cell arteritis.

Timeline

Start
2009-07
Primary completion
2014-09
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisone Other / unclassified

Indications