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

Phase 1

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: REGN475; Other: Placebo

• Registration Number: NCT00944892
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Study Start: 2009-08
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Disposition First Submitted: 2011-03-17
• Disposition First Submitted QC: 2011-03-17
• Disposition First Posted: 2011-03-28
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-01
• Last Update Posted: 2011-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 2	REGN475	-
Placebo	Placebo	-
Dose 1	REGN475	-
Dose 3	REGN475	-

Primary Outcome Measures

Name	Time	Method
The incidence of TEAEs in patients treated with REGN475 or placebo, reported between administration of study drug on Day 1 and the completion of study at the end of week 24 (Day 169).	24 weeks

Secondary Outcome Measures

Name	Time	Method
Patient assessment of response to treatment over time using the Patient Global Impression of Change.	24 weeks
Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).	24 weeks
Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) (total score as well as all 3 subscales: pain, stiffness and function).	24 weeks