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

This study has been completed.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals Identifier:
First received: July 21, 2009
Last updated: December 1, 2011
Last verified: December 2011

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.

Condition Intervention Phase
Osteoarthritis of the Knee Drug: REGN475 Other: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

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

Enrollment: 200
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 Drug: REGN475
2 Administrations of REGN475 within 24 weeks.
Experimental: Dose 2 Drug: REGN475
2 Administrations of REGN475 within 24 weeks.
Experimental: Dose 3 Drug: REGN475
2 Administrations of REGN475 within 24 weeks.
Placebo Comparator: Placebo Other: Placebo
Placebo to match REGN475 doses


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00944892

United States, California
Anaheim, California, United States
United States, Florida
Tampa, Florida, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT00944892     History of Changes
Other Study ID Numbers: R475-PN-0901
Study First Received: July 21, 2009
Last Updated: December 1, 2011

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on August 18, 2017