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OpenTrials
Completed

NCT Number: NCT00944892

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REGN475

Drug

2 Administrations of REGN475 within 24 weeks.

Placebo

Other

Placebo to match REGN475 doses

Primary outcomes

  1. 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

  1. 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

  2. Patient assessment of response to treatment over time using the Patient Global Impression of Change.

    Time frame: 24 weeks

  3. Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 23, 2009
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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