NCT01239017

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

First QC Date

November 9, 2010

Last Update Submit

March 16, 2015

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

    16 weeks

Secondary Outcomes (6)

  • Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).

    8 weeks

  • Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).

    8 weeks

  • Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    8 weeks

  • Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    8 weeks

  • Patient assessment of response to treatment over time using the Patient Global Impression of Change.

    16 weeks

  • +1 more secondary outcomes

Study Arms (5)

Dose 1

EXPERIMENTAL

SC REGN475 Dose 1 and IV Placebo

Biological: REGN475

Dose 2

EXPERIMENTAL

SC REGN475 Dose 2 and IV Placebo

Biological: REGN475

Dose 3

EXPERIMENTAL

SC REGN475 Dose 3 and IV Placebo

Biological: REGN475

Dose 4

EXPERIMENTAL

SC Placebo and IV REGN475 Dose 4

Biological: REGN475

Dose 5

PLACEBO COMPARATOR

SC Placebo and IV Placebo

Other: Placebo

Interventions

REGN475BIOLOGICAL
Dose 1Dose 2Dose 3Dose 4
PlaceboOTHER
Dose 5

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

fasinumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Paul J Tiseo, PhD

    Regeneron Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 11, 2010

Last Updated

March 18, 2015

Record last verified: 2015-03