Open-label Extension Study Of RN624

NCT ID: NCT00399490

Last Updated: 2021-02-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-15

Study Completion Date

2008-02-11

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis OA Knee Pain Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RN624 (PF-04383119)

Intervention Type DRUG

50 mcg/kg

Interventions

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RN624 (PF-04383119)

50 mcg/kg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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BrookWood Internal Medicine

Birmingham, Alabama, United States

Site Status

Radiant Research

Birmingham, Alabama, United States

Site Status

Arizona Research Center, LLC

Phoenix, Arizona, United States

Site Status

Imaging Centers of Anaheim

Anaheim, California, United States

Site Status

Orange County Clinical Research

Anaheim, California, United States

Site Status

Synergy Clinical Research Center

National City, California, United States

Site Status

David M. Radin, MD

Stamford, Connecticut, United States

Site Status

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status

Covance Clinical Research Unit, Inc

Daytona Beach, Florida, United States

Site Status

Ocala Rheumatology Research Center

Ocala, Florida, United States

Site Status

Tampa Medical Group, PA

Tampa, Florida, United States

Site Status

Habana Hospital Pharmacy

Tampa, Florida, United States

Site Status

Covance Clinical Research Unit, Inc. Honolulu

Honolulu, Hawaii, United States

Site Status

Covance Boise

Boise, Idaho, United States

Site Status

Northwest Indiana Center for Clinical Research

Merrillville, Indiana, United States

Site Status

Office of David Neustadt, PSL

Louisville, Kentucky, United States

Site Status

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, United States

Site Status

Quality Clincal Research

Omaha, Nebraska, United States

Site Status

Albuquerque Clinical Trials

Albuquerque, New Mexico, United States

Site Status

AAIR Research Center

Rochester, New York, United States

Site Status

Sports Medicine and Orthopaedics Center

Greensboro, North Carolina, United States

Site Status

Pharmquest

Greensboro, North Carolina, United States

Site Status

Pharmacotherapy Research Associates Incorporated

Zanesville, Ohio, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

Site Status

Volunteer Research Group

Knoxville, Tennessee, United States

Site Status

Office of Walter F. Chase, MD, PA

Austin, Texas, United States

Site Status

Radiant Research - San Antonio

San Antonio, Texas, United States

Site Status

Radiant Research San Antonio Northeast

San Antonio, Texas, United States

Site Status

Rheumatology Associates of South Texas

San Antonio, Texas, United States

Site Status

South Texas Radiology Imaging Center

San Antonio, Texas, United States

Site Status

Pivotal Research

Midvale, Utah, United States

Site Status

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status

Clinical Trials Northwest

Yakima, Washington, United States

Site Status

Countries

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United States

References

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Schnitzer TJ, Lane NE, Birbara C, Smith MD, Simpson SL, Brown MT. Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee pain. Osteoarthritis Cartilage. 2011 Jun;19(6):639-46. doi: 10.1016/j.joca.2011.01.009. Epub 2011 Jan 18.

Reference Type DERIVED
PMID: 21251985 (View on PubMed)

Related Links

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Other Identifiers

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RN624-CL007

Identifier Type: OTHER

Identifier Source: secondary_id

A4091009

Identifier Type: -

Identifier Source: org_study_id

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