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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis

Brief 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.

Detailed Summary:
Sponsor: University Hospital, Caen

Current Primary Outcome: oral clearance of prednisolone [ Time Frame: 2 to 4 weeks after begining prednisolone treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Caen

Dates:
Date Received: July 21, 2011
Date Started: July 2009
Date Completion: December 2014
Last Updated: April 8, 2014
Last Verified: April 2014