This trial is active, not recruiting.

Condition giant cell arteritis
Treatment prednisone therapy and pharmacokinetic
Phase phase 4
Sponsor University Hospital, Caen
Start date July 2009
End date September 2014
Trial size 150 participants
Trial identifier NCT01400464, 2008-004896-23


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

oral clearance of prednisolone
time frame: 2 to 4 weeks after begining prednisolone treatment

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by University Hospital, Caen.