A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee

Phase 2

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Biological: REGN475; Other: Placebo

• Registration Number: NCT01239017
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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.
2. 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. Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit.
4. Women who are pregnant or breast-feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose 1	REGN475	SC REGN475 Dose 1 and IV Placebo
Dose 4	REGN475	SC Placebo and IV REGN475 Dose 4
Dose 5	Placebo	SC Placebo and IV Placebo
Dose 2	REGN475	SC REGN475 Dose 2 and IV Placebo
Dose 3	REGN475	SC REGN475 Dose 3 and IV Placebo

Primary Outcome Measures

Name	Time	Method
The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.	16 weeks

Secondary Outcome Measures

Name	Time	Method
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