A Multicenter, Parallel, Double-Blind, Blinded Evaluator, Randomized Comparison of the Efficacy and Safety of an Alternate Viscosupplement (AVS-beta) to Methylprednisolone Acetate in Patients with Symptomatic Osteoarthritis of the Knee

Femme et Homme

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Extrait

This study has two primary objectives: The first objective of this study is to compare the safety and efficacy of 1 x 4-mL and 2 x 4-mL IA injections of AVS-beta against 1 x 1-mL (40 mg/mL) IA injection of methylprednisolone acetate in treating patients with symptomatic knee OA. Secondly, to demonstrate that the odds of positive response to treatment for symptomatic knee OA over 26 weeks (where positive response is defined with the OMERACT-OARSI [Pham et al., 2003, J Rheum] set of criteria) is higher in patients treated with a 1 x 4-mL and/or 2 x 4-mL IA injections of AVS-beta compared to patients treated with a course of methylprednisolone acetate

Critère d'inclusion

Osteoarthritis

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A Multicenter, Parallel, Double-Blind, Blinded Evaluator, Randomized Comparison of the Efficacy and Safety of an Alternate Viscosupplement (AVS-beta) to Methylprednisolone Acetate in Patients with Sym...