Extension Study Of Tanezumab In Osteoarthritis

NCT ID: NCT00809783

Last Updated: 2021-05-10

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-06

Study Completion Date

2011-06-23

Brief Summary

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Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

Detailed Description

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This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tanezumab 10 mg

Tanezumab 10 mg

Group Type EXPERIMENTAL

tanezumab

Intervention Type BIOLOGICAL

Tanezumab 10 mg

Tanezumab 5 mg

Tanezumab 5 mg

Group Type EXPERIMENTAL

tanezumab

Intervention Type BIOLOGICAL

Tanezumab 5 mg

Tanezumab 2.5 mg

Tanezumab 2.5 mg

Group Type EXPERIMENTAL

tanezumab

Intervention Type BIOLOGICAL

Tanezumab 2.5 mg

Interventions

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tanezumab

Tanezumab 10 mg

Intervention Type BIOLOGICAL

tanezumab

Tanezumab 5 mg

Intervention Type BIOLOGICAL

tanezumab

Tanezumab 2.5 mg

Intervention Type BIOLOGICAL

Other Intervention Names

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RN624 RN624 RN624

Eligibility Criteria

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Inclusion Criteria

* Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria

* Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 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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Pinncale Research Group, LLC

Anniston, Alabama, United States

Site Status

Anniston Medical Clinic, PC

Anniston, Alabama, United States

Site Status

Pinnacle Research Group, LLC

Anniston, Alabama, United States

Site Status

Greystone Medical Center

Birmingham, Alabama, United States

Site Status

Saadat Ansari, MD Office

Huntsville, Alabama, United States

Site Status

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Site Status

Horizon Research Group

Mobile, Alabama, United States

Site Status

Clinical Research Advantage, Inc./Mesa Family Medical Center, PC

Mesa, Arizona, United States

Site Status

Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC

Mesa, Arizona, United States

Site Status

Novara Clinical Research

Mesa, Arizona, United States

Site Status

Clinical Research Advantage, Inc.

Mesa, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Research, PLLC

Paradise Valley, Arizona, United States

Site Status

Pivotal Research Center

Peoria, Arizona, United States

Site Status

Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Clinical Research Advantage, Inc.

Phoenix, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States

Site Status

Paradigm Clinical, Inc.

Tucson, Arizona, United States

Site Status

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, United States

Site Status

Quality of Life Medical and Research Center

Tucson, Arizona, United States

Site Status

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

St. Joseph's Mercy Clinic

Hot Springs, Arkansas, United States

Site Status

Osteoporosis Medical Center

Beverly Hills, California, United States

Site Status

Providence Clinical Research

Burbank, California, United States

Site Status

eStudySite

Chula Vista, California, United States

Site Status

Colorado Hematology - Oncology

Englewood, California, United States

Site Status

Colorado Orthopedic Consultants, PC

Englewood, California, United States

Site Status

Arthritis Medical Clinic of North County, Inc.

Escondido, California, United States

Site Status

Edinger Medical Group Clinical Research

Fountain Valley, California, United States

Site Status

Valley Research

Fresno, California, United States

Site Status

Talbert Medical Group

Huntington Beach, California, United States

Site Status

Lakewood Orthopedic Medical & Surgical Group

Lakewood, California, United States

Site Status

High Desert Medical Group Research for Life

Lancaster, California, United States

Site Status

Premiere Clinical Research, LLC

Long Beach, California, United States

Site Status

Samaritan Center for Medical Research

Los Gatos, California, United States

Site Status

Del Carmen Medical Center

Reseda, California, United States

Site Status

Probe Clinical Research, Corp.

Santa Ana, California, United States

Site Status

Trinity Clinical Trials

Santa Ana, California, United States

Site Status

Office of Lawrence P McAdam, MD

Thousand Oaks, California, United States

Site Status

Westlake Medical Research

Westlake Village, California, United States

Site Status

Colorado Orthopedic Consultants, PC

Aurora, Colorado, United States

Site Status

Peak Anesthesia and Pain Management

Centennial, Colorado, United States

Site Status

Denver Internal Medicine Group

Denver, Colorado, United States

Site Status

Mountain View Clinical Research, Inc.

Denver, Colorado, United States

Site Status

Advanced Orthopedic and Sports Medicine

Denver, Colorado, United States

Site Status

American Clinical Research, LLC

Englewood, Colorado, United States

Site Status

Orthopaedic Physicians Of Colorado, P.C.

Englewood, Colorado, United States

Site Status

University Parks Hematology/Oncology

Englewood, Colorado, United States

Site Status

Advanced Orthopedic and Sports Medicine

Parker, Colorado, United States

Site Status

Clinical Research Center of Connecticut

Danbury, Connecticut, United States

Site Status

Norwalk Medical Group

Norwalk, Connecticut, United States

Site Status

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status

Delaware Arthritis

Lewes, Delaware, United States

Site Status

Javed Rheumatology Associates, Inc.

Newark, Delaware, United States

Site Status

HeartCare (Private Practice)

Bradenton, Florida, United States

Site Status

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status

Tampa Bay Medical Research, Inc.

Clearwater, Florida, United States

Site Status

Clinical Research of South Florida

Coral Gables, Florida, United States

Site Status

Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

Arthritis Associates of South Florida

Delray Beach, Florida, United States

Site Status

Delray Research Associates

Delray Beach, Florida, United States

Site Status

In Vivo Clinical Research, Inc

Doral, Florida, United States

Site Status

S & W Clinical Research

Fort Lauderdale, Florida, United States

Site Status

Centre for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, United States

Site Status

Westside Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Adult Medicine Specialists

Longwood, Florida, United States

Site Status

Genesis Research International

Longwood, Florida, United States

Site Status

Pharmax Research Clinic, Inc

Miami, Florida, United States

Site Status

Kendall South Medical Center, Inc.

Miami, Florida, United States

Site Status

Sunshine Research Center

Opa-locka, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

Rheumatology Associates of Central Florida

Orlando, Florida, United States

Site Status

The Arthritis Center

Palm Harbor, Florida, United States

Site Status

University Clinical Research Incorporated

Pembroke Pines, Florida, United States

Site Status

Advent Clinical Research Centers, Inc.

Pinellas Park, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

HeartCare Research

Sarasota, Florida, United States

Site Status

Dale G. Bramlet, MD, P.L.

St. Petersburg, Florida, United States

Site Status

West Broward Rheumatology Associates, Inc.

Tamarac, Florida, United States

Site Status

Tampa Medical Group, PA

Tampa, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

Laureate Clinical Research Group

Atlanta, Georgia, United States

Site Status

Arthritis and Rheumatology of Georgia

Atlanta, Georgia, United States

Site Status

Laureate Clinical Research Group

Atlanta, Georgia, United States

Site Status

Masters of Clinical Research, Inc.

Augusta, Georgia, United States

Site Status

River Birch Research Alliance, LLC

Blue Ridge, Georgia, United States

Site Status

Jefrey D. Lieberman, MD

Decatur, Georgia, United States

Site Status

Early Family Practice Center

Fort Valley, Georgia, United States

Site Status

Northeast Georgia Diagnostic Clinic, LLC

Gainesville, Georgia, United States

Site Status

Marietta Rheumatology Associates

Marietta, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

North Georgia Internal Medicine

Woodstock, Georgia, United States

Site Status

Sonora Clinical Research, LLC.

Boise, Idaho, United States

Site Status

Millennium Pain Center

Bloomington, Illinois, United States

Site Status

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Site Status

Koch Family Medicine

Morton, Illinois, United States

Site Status

Illinois Bone and Joint Institute, LLC

Morton Grove, Illinois, United States

Site Status

The Arthritis Center

Springfield, Illinois, United States

Site Status

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

Site Status

American Health Network

Fishers, Indiana, United States

Site Status

Memorial Medical Group Clinical Research Institute

South Bend, Indiana, United States

Site Status

Northwest Indiana Center for Clinical Research

Valparaiso, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Integrated Clinical Trial Services, Inc.

West Des Moines, Iowa, United States

Site Status

Professional Research Network of Kansas, LLC

Wichita, Kansas, United States

Site Status

Pasadena Pharmacy

Lexington, Kentucky, United States

Site Status

The Pain Treatment Center of the Bluegrass

Lexington, Kentucky, United States

Site Status

Arthritis Center of Lexington

Lexington, Kentucky, United States

Site Status

Bluegrass Community Research, Inc

Lexington, Kentucky, United States

Site Status

David H. Neustadt, MD

Louisville, Kentucky, United States

Site Status

L-Marc Research Center

Louisville, Kentucky, United States

Site Status

Bone and Joint Clinic of Baton Rouge

Baton Rouge, Louisiana, United States

Site Status

Gulf Coast Research, LLC

Baton Rouge, Louisiana, United States

Site Status

The Baton Rouge Clinic

Baton Rouge, Louisiana, United States

Site Status

Stanocola Medical Center

Baton Rouge, Louisiana, United States

Site Status

Arthritis and Diabetes Clinic

Monroe, Louisiana, United States

Site Status

Maine Research Associates

Auburn, Maine, United States

Site Status

Arthritis Treatment Center

Frederick, Maryland, United States

Site Status

Mid-Atlantic Medical Research Centers

Hollywood, Maryland, United States

Site Status

The Center for Rheumatology and Bone Research

Wheaton, Maryland, United States

Site Status

Beacon Clinical Research, LLC

Brockton, Massachusetts, United States

Site Status

Miray Medical Center

Brockton, Massachusetts, United States

Site Status

Mansfield Health Center

Mansfield, Massachusetts, United States

Site Status

Arthritis Associates Inc.

Peabody, Massachusetts, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Ann Arbor Clinical Research

Ann Arbor, Michigan, United States

Site Status

Great Lakes Research Group, Incorporated

Bay City, Michigan, United States

Site Status

KMED Research

Saint Clair Shores, Michigan, United States

Site Status

MAPS Applied Research Center Inc.

Edina, Minnesota, United States

Site Status

Medical Advanced Pain Specialists

Edina, Minnesota, United States

Site Status

Planters Clinic

Port Gibson, Mississippi, United States

Site Status

St. John's Clinic - Neurology

Springfield, Missouri, United States

Site Status

St. John's Medical Research Institute, Inc.

Springfield, Missouri, United States

Site Status

Medex Healthcare Research

St Louis, Missouri, United States

Site Status

Mercy Health Research

St Louis, Missouri, United States

Site Status

Midwest Minor Medical

Omaha, Nebraska, United States

Site Status

Quality Clinical Research, Inc.

Omaha, Nebraska, United States

Site Status

Midwest Minor Medical

Omaha, Nebraska, United States

Site Status

Midwest Minor Medical

Omaha, Nebraska, United States

Site Status

Diagnostic Center of Medicine

Henderson, Nevada, United States

Site Status

Independent Clinical Researchers

Las Vegas, Nevada, United States

Site Status

Wolfson Medical Center

Las Vegas, Nevada, United States

Site Status

Clinical Research Consortium

Las Vegas, Nevada, United States

Site Status

Mirkil Medical

Las Vegas, Nevada, United States

Site Status

G. Timothy Kelly, MD

Las Vegas, Nevada, United States

Site Status

Office of Dr. Danka Michaels, MD

Las Vegas, Nevada, United States

Site Status

Comprehensive Clinical Research

Berlin, New Jersey, United States

Site Status

Albuquerque Clinical Trials

Albuquerque, New Mexico, United States

Site Status

New Mexico Clinical Research & Osteoporosis Center, Incorporated

Albuquerque, New Mexico, United States

Site Status

Arthritis and Osteoporosis Medical Associates

Brooklyn, New York, United States

Site Status

Medex Healthcare Research

New York, New York, United States

Site Status

The Medical Research Network, LLC

New York, New York, United States

Site Status

Prem C. Chatpar, MD, LLC

Plainview, New York, United States

Site Status

AAIR Research Center

Rochester, New York, United States

Site Status

Office of Dr. Andrew Porges

Roslyn, New York, United States

Site Status

SPRI Bronx LLC

The Bronx, New York, United States

Site Status

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, United States

Site Status

Carolina Bone & Joint, PA

Charlotte, North Carolina, United States

Site Status

Pharmquest

Greensboro, North Carolina, United States

Site Status

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

Odyssey Research

Fargo, North Dakota, United States

Site Status

Plains Medical Clinic, LLC

Fargo, North Dakota, United States

Site Status

Consultants for Clinical Research Incorporated

Cincinnati, Ohio, United States

Site Status

Ohio GI and Liver Institute

Cincinnati, Ohio, United States

Site Status

Hilltop Medical Research Center

Cincinnati, Ohio, United States

Site Status

Columbus Clinical Research, Inc.

Columbus, Ohio, United States

Site Status

PHP Center for Clinical Research

Dayton, Ohio, United States

Site Status

Paramount Medical Research and Consulting, LLC

Middleburg Heights, Ohio, United States

Site Status

Orthopaedic & Sports Medicine Consultants

Middletown, Ohio, United States

Site Status

Signal Point Clinical Research Center

Middletown, Ohio, United States

Site Status

Pharmacotherapy Research Associates,Inc

Zanesville, Ohio, United States

Site Status

Physicians' Research, Inc

Zanesville, Ohio, United States

Site Status

Primecare of Southeastern Ohio, Inc

Zanesville, Ohio, United States

Site Status

Cor Clinical Research, LLC

Oklahoma City, Oklahoma, United States

Site Status

Health Research Institute

Oklahoma City, Oklahoma, United States

Site Status

East Penn Rheumatology Associates, PC

Bethlehem, Pennsylvania, United States

Site Status

Brandywine Clinical Research

Downingtown, Pennsylvania, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Clinical Research Center of Reading, LLP

Wyomissing, Pennsylvania, United States

Site Status

Low Country Rheumatology, PA

Charleston, South Carolina, United States

Site Status

The Family Healthcare Center, PA

Clinton, South Carolina, United States

Site Status

Southern Orthopaedic Sports Medicine

Columbia, South Carolina, United States

Site Status

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Site Status

The Carolina Center for Rheumatology and Arthritis Care, PA

Rock Hill, South Carolina, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

State of Franklin Healthcare Associates, PLLC

Johnson City, Tennessee, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

Capitol Medical Clinic

Austin, Texas, United States

Site Status

Walter F. Chase, MD, PA

Austin, Texas, United States

Site Status

Tekton Research, Inc.

Austin, Texas, United States

Site Status

North Texas Joint Care, PA

Dallas, Texas, United States

Site Status

Crown Imaging

Dallas, Texas, United States

Site Status

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status

Radiant Research

Dallas, Texas, United States

Site Status

O. David Taunton, Jr, MD

Grapevine, Texas, United States

Site Status

Asif Cochinwala, MD, PA

Houston, Texas, United States

Site Status

Foundation for Southwest Orthopedic Research

Houston, Texas, United States

Site Status

One Step Diagnostic

Houston, Texas, United States

Site Status

Southwest Orthopedic Group

Houston, Texas, United States

Site Status

The Neurology Center

Houston, Texas, United States

Site Status

Pioneer Research Solutions, Inc.

Houston, Texas, United States

Site Status

Gill Orthopedic Center

Lubbock, Texas, United States

Site Status

Robert R. King, M.D.

Lubbock, Texas, United States

Site Status

Clinical Investigations of Texas, LLC

Plano, Texas, United States

Site Status

Radiant Research San Antonio Northeast

San Antonio, Texas, United States

Site Status

Texas Arthritis Research Center, PA

San Antonio, Texas, United States

Site Status

Diagnostics Research Group

San Antonio, Texas, United States

Site Status

Spring Family Practice Associates PA

Spring, Texas, United States

Site Status

AZ Clinical Research

Sugar Land, Texas, United States

Site Status

Spring Clinical Research

Sugar Land, Texas, United States

Site Status

Sugar Land Med-Ped, P.A.

Sugar Land, Texas, United States

Site Status

Grayline Clinical Drug Trials

Wichita Falls, Texas, United States

Site Status

Aspen Clinical Research

Orem, Utah, United States

Site Status

Foothill Family Clinic

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Incorporated/Foothill Family Clinic South

Salt Lake City, Utah, United States

Site Status

Commonwealth Orthopaedics and Rehabilitation, PC

Arlington, Virginia, United States

Site Status

IntegraTrials, LLC

Arlington, Virginia, United States

Site Status

Virginia Hospital Center

Arlington, Virginia, United States

Site Status

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status

National Clinical Research - Norfolk, Inc.

Norfolk, Virginia, United States

Site Status

Office of Doris M. Rice, MD, FACR

Portsmouth, Virginia, United States

Site Status

HhypotheTest, LLC

Roanoke, Virginia, United States

Site Status

Empirical Clinical Trials

Selah, Washington, United States

Site Status

Arthritis Northwest

Spokane, Washington, 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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Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.

Reference Type DERIVED
PMID: 26554876 (View on PubMed)

Related Links

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Other Identifiers

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P3 LONG TERM SAFETY EXTENSION

Identifier Type: OTHER

Identifier Source: secondary_id

A4091016

Identifier Type: -

Identifier Source: org_study_id

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