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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239017
First Posted: November 11, 2010
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by:
Regeneron Pharmaceuticals
  Purpose

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.


Condition Intervention Phase
Osteoarthritis Biological: REGN475 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo. [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS). [ Time Frame: 8 weeks ]
  • Change from baseline in walking knee pain using the Numeric Rating Scale (NRS). [ Time Frame: 8 weeks ]
  • Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: 8 weeks ]
  • Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: 8 weeks ]
  • Patient assessment of response to treatment over time using the Patient Global Impression of Change. [ Time Frame: 16 weeks ]
  • Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12). [ Time Frame: 8 weeks ]

Enrollment: 0
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239017


Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Paul J Tiseo, PhD Regeneron Pharmaceuticals
  More Information

Responsible Party: Paul Tiseo, PhD - Medical Director, Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01239017     History of Changes
Other Study ID Numbers: R475-PN-1004
First Submitted: November 9, 2010
First Posted: November 11, 2010
Last Update Posted: March 18, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases