NCT00944892

A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee

A Randomized,Double Blind,Placebo-controlled,Parallel Group,Repeat Dose Study of the Safety and Efficacy of REGN475 in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 4 treatment arms (3 active and 1 placebo). Each patient will receive two doses of active medication or placebo, with study drug administered intravenously (IV). The primary goal of the study is to assess the safety and tolerability of repeat administrations of REGN475 compared to placebo in patients with osteoarthritis (OA) of the knee.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	REGN475	2 Administrations of REGN475 within 24 weeks.
OTHER	Placebo	Placebo to match REGN475 doses

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-07-23
• Last updated: 2011-12-08

Locations

3 sites across 1 country: United States