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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01239017
• Other study ID #: R475-PN-1004
• Status: Withdrawn
• Phase: Phase 2
• First received: November 9, 2010
• Last updated: March 16, 2015

Study information

• Verified date: March 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• REGN475

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.		16 weeks	Yes
Secondary	Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).		8 weeks	No
Secondary	Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).		8 weeks	No
Secondary	Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)		8 weeks	No
Secondary	Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)		8 weeks	No
Secondary	Patient assessment of response to treatment over time using the Patient Global Impression of Change.		16 weeks	No
Secondary	Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).		8 weeks	No