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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.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00944892
First received: July 21, 2009
Last updated: December 1, 2011
Last verified: December 2011
History of Changes
  Purpose

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: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Patient assessment of response to treatment over time using the Patient Global Impression of Change. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944892

Locations
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
Sanofi
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00944892     History of Changes
Other Study ID Numbers: R475-PN-0901
Study First Received: July 21, 2009
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013