Status:
COMPLETED
A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00944892
Start Date
August 1 2009
End Date
May 1 2010
Last Update
December 8 2011
Active Locations (3)
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1
Anaheim, California, United States
2
Tampa, Florida, United States
3
Salt Lake City, Utah, United States