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

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
REGN475
Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Dose 1

    Dose 2

    Dose 3

    Dose 4

    Dose 5

    Arm Description

    SC REGN475 Dose 1 and IV Placebo

    SC REGN475 Dose 2 and IV Placebo

    SC REGN475 Dose 3 and IV Placebo

    SC Placebo and IV REGN475 Dose 4

    SC Placebo and IV Placebo

    Outcomes

    Primary Outcome Measures

    The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 9, 2010
    Last Updated
    March 16, 2015
    Sponsor
    Regeneron Pharmaceuticals
    Collaborators
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01239017
    Brief Title
    A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Regeneron Pharmaceuticals
    Collaborators
    Sanofi

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dose 1
    Arm Type
    Experimental
    Arm Description
    SC REGN475 Dose 1 and IV Placebo
    Arm Title
    Dose 2
    Arm Type
    Experimental
    Arm Description
    SC REGN475 Dose 2 and IV Placebo
    Arm Title
    Dose 3
    Arm Type
    Experimental
    Arm Description
    SC REGN475 Dose 3 and IV Placebo
    Arm Title
    Dose 4
    Arm Type
    Experimental
    Arm Description
    SC Placebo and IV REGN475 Dose 4
    Arm Title
    Dose 5
    Arm Type
    Placebo Comparator
    Arm Description
    SC Placebo and IV Placebo
    Intervention Type
    Biological
    Intervention Name(s)
    REGN475
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
    Time Frame
    8 weeks
    Title
    Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
    Time Frame
    8 weeks
    Title
    Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
    Time Frame
    8 weeks
    Title
    Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
    Time Frame
    8 weeks
    Title
    Patient assessment of response to treatment over time using the Patient Global Impression of Change.
    Time Frame
    16 weeks
    Title
    Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening. Exclusion Criteria: 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. Patients with joint replacement in the affected knee. Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit. Women who are pregnant or breast-feeding.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul J Tiseo, PhD
    Organizational Affiliation
    Regeneron Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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