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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Sanofi
• Treatments: Fasinumab

Criteria

Inclusion Criteria:

1. Men and women ≥ 40 and ≤ 75 years of age.

2. Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.

3. Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.

Exclusion Criteria:

1. Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.

2. Patients with joint replacement in the affected knee.

3. Patients with peripheral neuropathy due to any reason.