Arthritis Clinical Trials

This study will be a multi-center, randomized, double-blind, active comparator, parallel-group, single dose design.

Up to 224 patients with knee OA will be randomized to be treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of Kenalog-40.

Each patient will be evaluated for a total of 12 weeks following a single IA injection. Following screening, safety and efficacy and PK will be evaluated at 7 out-patient visits (Days 1 [Baseline], 2, 8, 15, 29, 57 and 85).

Analgesic effect will be assessed using weekly average of daily (24 hour) pain intensity score, Western Ontario & McMaster University Osteoarthritis Index (WOMAC) and patient and clinical global impression of change.