A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain

October 7, 2009 updated by: Pfizer

A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety and Efficacy of RN624 in Adults With Moderate-to-Severe Pain Due to Osteoarthritis of the Knee

The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624 compared to placebo over a 4 month period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
      • Cypress, California, United States, 90630
        • Pfizer Investigational Site
      • National City, California, United States, 91950
        • Pfizer Investigational Site
      • Sacremento, California, United States, 95817
        • Pfizer Investigational Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Pfizer Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Pfizer Investigational Site
      • North Miami, Florida, United States, 33161
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614-7118
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Pfizer Investigational Site
      • Honolulu, Hawaii, United States, 96814
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Pfizer Investigational Site
      • Merrillville, Indiana, United States, 46410
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21224-6821
        • Pfizer Investigational Site
      • Wheaton, Maryland, United States, 20902
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Pfizer Investigational Site
      • Reno, Nevada, United States, 89502
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
    • New York
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28210-8503
        • Pfizer Investigational Site
      • Greensboro, North Carolina, United States, 27401
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27612
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Pfizer Investigational Site
      • Zanesville, Ohio, United States, 43701
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site
    • Utah
      • Midvale, Utah, United States, 84047
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Pfizer Investigational Site
    • Washington
      • Yakima, Washington, United States, 98902
        • Pfizer Investigational Site

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:

Male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to OA (scoring 50 out of 100 on a visual analog scale on knee pain).

Subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery

Exclusion Criteria:

History or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or IgG-fusion proteins, Hepatitis B, C or HIV, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: RN624 (PF-04383119)
10 mcg/kg
Drug: RN624 (PF-04383119)
25 mcg/kg
Drug: RN624 (PF-04383119)
50 mcg/kg
Drug: RN624 (PF-04383119)
100 mcg/kg
Drug: RN624 (PF-04383119)
200 mcg/kg
Placebo Comparator: placebo
Drug: placebo
Experimental: 3
Drug: RN624 (PF-04383119)
10 mcg/kg
Drug: RN624 (PF-04383119)
25 mcg/kg
Drug: RN624 (PF-04383119)
50 mcg/kg
Drug: RN624 (PF-04383119)
100 mcg/kg
Drug: RN624 (PF-04383119)
200 mcg/kg
Experimental: 4
Drug: RN624 (PF-04383119)
10 mcg/kg
Drug: RN624 (PF-04383119)
25 mcg/kg
Drug: RN624 (PF-04383119)
50 mcg/kg
Drug: RN624 (PF-04383119)
100 mcg/kg
Drug: RN624 (PF-04383119)
200 mcg/kg
Experimental: 5
Drug: RN624 (PF-04383119)
10 mcg/kg
Drug: RN624 (PF-04383119)
25 mcg/kg
Drug: RN624 (PF-04383119)
50 mcg/kg
Drug: RN624 (PF-04383119)
100 mcg/kg
Drug: RN624 (PF-04383119)
200 mcg/kg
Experimental: 1
monoclonal antibody
Drug: RN624 (PF-04383119)
10 mcg/kg
Drug: RN624 (PF-04383119)
25 mcg/kg
Drug: RN624 (PF-04383119)
50 mcg/kg
Drug: RN624 (PF-04383119)
100 mcg/kg
Drug: RN624 (PF-04383119)
200 mcg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Walking knee pain scores
Time Frame: Day 112
Day 112

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall knee pain scores
Time Frame: Day 112
Day 112
Incidence of adverse events and serious adverse events
Time Frame: Day 112
Day 112
WOMAC
Time Frame: Day 112
Day 112

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 30, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (Estimate)

November 1, 2006

Study Record Updates

Last Update Posted (Estimate)

October 12, 2009

Last Update Submitted That Met QC Criteria

October 7, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4091008
  • RN624-CL006

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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