NCT01239017
Withdrawn
Phase 2
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
ConditionsOsteoarthritis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Regeneron Pharmaceuticals
- Primary Endpoint
- The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
Time Frame: 16 weeks
Secondary Outcomes
- Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).(8 weeks)
- Patient assessment of response to treatment over time using the Patient Global Impression of Change.(16 weeks)
- Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).(8 weeks)
- Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).(8 weeks)
- Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)(8 weeks)
- Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)(8 weeks)
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