5 results
Primary: To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient*s assessment of gout pain intensity in the target joint at 72 hours post-dose (on a 0-100mm VAS). To confirm that canakinumab…
The study objectives are:- to characterize the biotransformation pathways, the routes and rates of excretion, and total recovery of the 14C-labeled research medication and its radiolabeled metabolites- to characterize the pharmacokinetics (PK) of…
To determine whether fibrinogen concentrate infusion reduces perioperative blood loss and transfusion in patient experiencing clinically relevant microvascular bleeding during elective complex cardiac surgery and to determine whether its use is safe…
Primary: Long term safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.