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Trial record 1 of 1 for:    NCT00399490
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Open-label Extension Study Of RN624

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00399490
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : November 4, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.

Condition or disease Intervention/treatment Phase
Osteoarthritis OA Knee Pain Arthritis Drug: RN624 (PF-04383119) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Multiple-Dose Study Of The Safety And Efficacy Of RN624 In Adults With Pain Due To Osteoarthritis Of The Knee
Study Start Date : September 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 1 Drug: RN624 (PF-04383119)
50 mcg/kg




Primary Outcome Measures :
  1. Incidence of adverse events

Secondary Outcome Measures :
  1. Drop-out rate, time to drop-out, and reasons for drop out
  2. WOMAC subscales and average
  3. Subject global assessment
  4. SF-36


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in Study RN624-CL006

Exclusion Criteria:

  • The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension
  • Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399490


Locations
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United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
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
United States, Connecticut
Pfizer Investigational Site
Stamford, Connecticut, United States, 06905
United States, Florida
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32114
Pfizer Investigational Site
Ocala, Florida, United States, 34474-7455
Pfizer Investigational Site
Tampa, Florida, United States, 33614-7118
United States, Hawaii
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
Merrillville, Indiana, United States, 46410
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
United States, Maryland
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
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
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
Greensboro, North Carolina, United States, 27401
Pfizer Investigational Site
Greensboro, North Carolina, United States, 27408
United States, Ohio
Pfizer Investigational Site
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
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
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00399490    
Other Study ID Numbers: A4091009
RN624-CL007
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: October 2009
Keywords provided by Pfizer:
Monoclonal antibody
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tanezumab
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs