Text Size

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This study has been withdrawn prior to enrollment.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:
Collaborator:
Sanofi
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01239017
First received: November 9, 2010
Last updated: April 17, 2011
Last verified: April 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in walking knee pain using the Numeric Rating Scale (NRS). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patient assessment of response to treatment over time using the Patient Global Impression of Change. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239017

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

No publications provided

Responsible Party: Paul Tiseo, PhD - Medical Director, Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01239017     History of Changes
Other Study ID Numbers: R475-PN-1004
Study First Received: November 9, 2010
Last Updated: April 17, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013