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

NCT ID: NCT00944892

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1

Group Type EXPERIMENTAL

REGN475

Intervention Type DRUG

2 Administrations of REGN475 within 24 weeks.

Dose 2

Group Type EXPERIMENTAL

REGN475

Intervention Type DRUG

2 Administrations of REGN475 within 24 weeks.

Dose 3

Group Type EXPERIMENTAL

REGN475

Intervention Type DRUG

2 Administrations of REGN475 within 24 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo to match REGN475 doses

Interventions

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REGN475

2 Administrations of REGN475 within 24 weeks.

Intervention Type DRUG

Placebo

Placebo to match REGN475 doses

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anaheim, California, United States

Site Status

Tampa, Florida, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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R475-PN-0901

Identifier Type: -

Identifier Source: org_study_id