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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00394563
First received: October 30, 2006
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Drug: RN624 (PF-04383119)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Walking knee pain scores [ Time Frame: Day 112 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall knee pain scores [ Time Frame: Day 112 ] [ Designated as safety issue: No ]
  • Incidence of adverse events and serious adverse events [ Time Frame: Day 112 ] [ Designated as safety issue: Yes ]
  • WOMAC [ Time Frame: Day 112 ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
monoclonal antibody
Drug: RN624 (PF-04383119)
10 mcg/kg
Experimental: 2 Drug: RN624 (PF-04383119)
25 mcg/kg
Experimental: 3 Drug: RN624 (PF-04383119)
50 mcg/kg
Experimental: 4 Drug: RN624 (PF-04383119)
100 mcg/kg
Experimental: 5 Drug: RN624 (PF-04383119)
200 mcg/kg
Placebo Comparator: placebo Drug: placebo

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394563

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
Pfizer Investigational Site
Tucson, Arizona, United States, 85712
United States, California
Pfizer Investigational Site
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
United States, Connecticut
Pfizer Investigational Site
Stamford, Connecticut, United States, 06905
Pfizer Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Pfizer Investigational Site
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
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96813
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83704
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47713
Pfizer Investigational Site
Merrillville, Indiana, United States, 46410
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21224-6821
Pfizer Investigational Site
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01610
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89123
Pfizer Investigational Site
Reno, Nevada, United States, 89502
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210-8503
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
Greensboro, North Carolina, United States, 27401
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43212
Pfizer Investigational Site
Zanesville, Ohio, United States, 43701
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pfizer Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Pfizer Investigational Site
Jackson, Tennessee, United States, 38305
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
San Antonio, Texas, United States, 78217
United States, Utah
Pfizer Investigational Site
Midvale, Utah, United States, 84047
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22911
United States, Washington
Pfizer Investigational Site
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00394563     History of Changes
Other Study ID Numbers: A4091008, RN624-CL006
Study First Received: October 30, 2006
Last Updated: October 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
osteoarthritis monoclonal antibody

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014