Giant Cell Arteritis
Conditions
Keywords
Giant Cell Arteritis, prednisone, pharmacokinetics
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.
Interventions
DRUGPrednisone therapy and pharmacokinetic
Prednisone therapy delivered in accordance with a 10 to 18 month pre-defined schedule. Pharmacokinetic and pharmacogenetic tests at 14 or 28 days. Monthly visit for the first 6 month, then every 8 weeks months thereafter for the remainder of the study with standard biologic monitoring , physical exam and medical and medication history .Also, participants will be asked to complete several questionnaires to assess quality of life and observance to therapy. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.
Sponsors
University Hospital, Caen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oral clearance of prednisolone | 2 to 4 weeks after begining prednisolone treatment |
Countries
France
Outcome results
None listed