Back to resultsA Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
REGN475
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Dose 1
Dose 2
Dose 3
Placebo
Arm Description
Outcomes
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).
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).
Patient assessment of response to treatment over time using the Patient Global Impression of Change.
Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).
Full Information
NCT ID
NCT00944892
First Posted
July 21, 2009
Last Updated
December 1, 2011
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00944892
Brief Title
A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1
Arm Type
Experimental
Arm Title
Dose 2
Arm Type
Experimental
Arm Title
Dose 3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
REGN475
Intervention Description
2 Administrations of REGN475 within 24 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo to match REGN475 doses
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Patient assessment of response to treatment over time using the Patient Global Impression of Change.
Time Frame
24 weeks
Title
Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Anaheim
State/Province
California
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee
We'll reach out to this number within 24 hrs