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

March 16, 2015 updated by: Regeneron Pharmaceuticals

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

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Biological: REGN475
Experimental: Dose 2
SC REGN475 Dose 2 and IV Placebo
Biological: REGN475
Experimental: Dose 3
SC REGN475 Dose 3 and IV Placebo
Biological: REGN475
Experimental: Dose 4
SC Placebo and IV REGN475 Dose 4
Biological: REGN475
Placebo Comparator: Dose 5
SC Placebo and IV Placebo
Other: 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

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Investigators

  • Study Director: Paul J Tiseo, PhD, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

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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