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

Phase 4

• Conditions: Giant Cell Arteritis

• Registration Number: NCT01400464
• Lead Sponsor: University Hospital, Caen

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 Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-22
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09
• Primary Completion: 2014-09
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:

  1. At least 50 years of age at disease onset
  2. New onset or new type of localized pain in the head
  3. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
  4. ESR of greater than 40 mm in the first hour by the Westergren method
  5. Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells

• Corticoid treatment since less than 14 days

• Signed informed consent

• Affiliation to the social security system

Exclusion Criteria

• Dementia
• Predictable non observance
• Neoplasia since less than 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
oral clearance of prednisolone	2 to 4 weeks after begining prednisolone treatment

Trial Locations

Locations (12)

CHU de Lille; 🇫🇷 Lille, France

CHU Jean Verdier (AP-HP); 🇫🇷 Bondy, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Rouen; 🇫🇷 Rouen, France

Centre Hospitalier Universitaire de Toulouse; 🇫🇷 Toulouse, Etat, France

Hôpital Pitié-Salpêtrière-APHP; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Limoges; 🇫🇷 Limoges, France

Hôpital Cochin-APHP; 🇫🇷 Paris, Etat, France

CHU de CAEN; 🇫🇷 Caen, Etat, France

CHU Avicennes; 🇫🇷 Bobigny, France

CH de Valenciennes; 🇫🇷 Valenciennes, Etat, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France