Clinical trial NCT01400464: Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Official title: Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Giant Cell Arteritis
Keywords: Giant Cell Arteritis
prednisone
pharmacokinetics
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: oral clearance of prednisolone
timeFrame: 2 to 4 weeks after begining prednisolone treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de CAEN
state: Etat
city: Paris
country: France
facility: Hôpital Cochin-APHP
state: Etat
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
state: Etat
city: Valenciennes
country: France
facility: CH de Valenciennes
state: Etat
city: Bobigny
country: France
facility: CHU Avicennes
city: Bondy
country: France
facility: CHU Jean Verdier (AP-HP)
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Lille
country: France
facility: CHU de Lille
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière-APHP
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
References: