Status:
UNKNOWN
Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
Lead Sponsor:
University Hospital, Caen
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:
- At least 50 years of age at disease onset
- New onset or new type of localized pain in the head
- Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
- ESR of greater than 40 mm in the first hour by the Westergren method
- 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
- Dementia
- Predictable non observance
- Neoplasia since less than 5 years
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01400464
Start Date
July 1 2009
End Date
December 1 2014
Last Update
April 9 2014
Active Locations (12)
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1
CHU de CAEN
Caen, Etat, France, 14000
2
Hôpital Cochin-APHP
Paris, Etat, France, 75679
3
Centre Hospitalier Universitaire de Toulouse
Toulouse, Etat, France, 31000
4
CH de Valenciennes
Valenciennes, Etat, France, 59300