- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01239017
A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Single Dose Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo).
Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive placebo SC.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit.
- Women who are pregnant or breast-feeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose 1
SC REGN475 Dose 1 and IV Placebo
|
|
Experimental: Dose 2
SC REGN475 Dose 2 and IV Placebo
|
|
Experimental: Dose 3
SC REGN475 Dose 3 and IV Placebo
|
|
Experimental: Dose 4
SC Placebo and IV REGN475 Dose 4
|
|
Placebo Comparator: Dose 5
SC Placebo and IV Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
Time Frame: 8 weeks
|
8 weeks
|
Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
Time Frame: 8 weeks
|
8 weeks
|
Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time Frame: 8 weeks
|
8 weeks
|
Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time Frame: 8 weeks
|
8 weeks
|
Patient assessment of response to treatment over time using the Patient Global Impression of Change.
Time Frame: 16 weeks
|
16 weeks
|
Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Paul J Tiseo, PhD, Regeneron Pharmaceuticals
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R475-PN-1004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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