10
Participants
Start Date
December 31, 2006
Primary Completion Date
April 30, 2008
Study Completion Date
April 30, 2008
Rilonacept
Lyophilized rilonacept will be supplied by Regeneron Pharmaceuticals at 160 mg/vial and reconstituted with 2.3 mL of sterile water for injection by the Clinical Center Pharmacy Intravenous Admixture Unit. The formulation contains 80 mg/mL rilonacept, histidine, citrate, PEG 3350, polysorbate 20, glycine, arginine, and sucrose (pH 6.5). Matching placebo in the identical formulation will also be supplied, and also reconstituted with 2.3 mL of sterile water for injection. Each administration of study drug will consist of two syringes containing 2.0 mL in each syringe (320 mg total drug).
Placebo
Normal saline subcutaneously at each treatment visit.
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
National Heart, Lung, and Blood Institute (NHLBI)
NIH