Giant Cell Arteritis (GCA, temporal arteritis) is a vasculitis of the medium and large-sized arteries that usually presents with headache and visual disturbances in patients over the age of fifty. Conventional treatment with oral glucocorticoid (GC, steroid, prednisone) for up to two to three years has been the only known efficacious therapy to suppress the inflammatory process and prevent associated vascular complications. However, the long duration and the cumulative dose of GC therapy frequently results in multiple adverse effect. Recent studies have shown several relapses and persistence of inflammation based on elevated inflammatory markers such as interleulin-6 despite timely oral GC therapy. Investigations on animal models suggest the need for much higher doses of GC to appropriately treat the vasculitic process. This forms the basis of our proposed study which is a randomized, double-blinded, placebo-controlled, prospective clinical trial where biopsy proven GCA patients will be treated with high dose pulse intravenous (IV) GC initially followed by lower doses of oral GC. We hypothesize that this will result in shorter length of therapy with lower dose of GC and hence reduced adverse effects.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000585-30
Application #
6415507
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
30
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
City
Rochester
State
MN
Country
United States
Zip Code
55905
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