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

Regeneron Pharmaceuticals0 sites200 target enrollmentAugust 2009

ConditionsOsteoarthritis of the Knee

InterventionsREGN475 Placebo

DrugsREGN475

Overview

Phase: Phase 1
Intervention: REGN475
Conditions: Osteoarthritis of the Knee
Sponsor: Regeneron Pharmaceuticals
Enrollment: 200
Primary Endpoint: 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).
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

May 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women ≥ 40 and ≤ 75 years of age.
•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.
•Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.

Exclusion Criteria

•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.
•Patients with joint replacement in the affected knee.
•Patients with peripheral neuropathy due to any reason.

Arms & Interventions

Dose 3

Intervention: REGN475

Placebo

Intervention: Placebo

Dose 1

Intervention: REGN475

Dose 2

Intervention: REGN475

Outcomes

Primary Outcomes

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).

Time Frame: 24 weeks

Secondary Outcomes

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)