A randomized, double blind, placebo and Naproxen controlled, multi-center, study to determine the safety, tolerability, pharmacokinetics and effect on pain of a single intra-articular administration of Canakinumab (anti-IL1? antibody) in patients with ost
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Last updated:9th Feb 2010
Part A : To determine the safety and tolerability of single ascending doses of an intra-articular administration of ACZ885 in subjects with osteoarthritis in the knee. Part B : To evaluate the clinical benefit in subjects with osteoarthritis in the knee, as measured by the change in the pain by using 100 mm VAS scale from baseline to day 4 (primary) and in the Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale from baseline to week 4 (step-down primary) of a single administration of ACZ885 (i.a.) in comparison to placebo.
|Study start date||2010-02-09|