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Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

NCT ID: NCT01089725

Last Updated: 2021-05-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-30

Study Completion Date

2011-02-18

Brief Summary

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This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.

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Detailed Description

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This study was terminated on 08 Nov 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 Arthritis Pain

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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Placebo

Group Type PLACEBO_COMPARATOR

Placebo IV

Intervention Type BIOLOGICAL

1 ml of placebo administered SC and IV once every 8 weeks.

Placebo SC

Intervention Type BIOLOGICAL

1 ml of placebo administered SC and IV once every 8 weeks.

2.5 mg tanezumab SC and placebo IV

Group Type EXPERIMENTAL

Tanezumab SC

Intervention Type BIOLOGICAL

1 ml tanezumab injection SC administered every 8 weeks

Placebo IV

Intervention Type BIOLOGICAL

1 ml placebo administered IV every 8 weeks

5 mg tanezumab SC and placebo IV

Group Type EXPERIMENTAL

Tanezumab SC

Intervention Type BIOLOGICAL

1 ml tanezumab injection SC administered every 8 weeks

Placebo IV

Intervention Type BIOLOGICAL

1ml placebo administered IV every 8 weeks

10 mg tanezumab SC and placebo IV

Group Type EXPERIMENTAL

Tanezumab SC

Intervention Type BIOLOGICAL

1 ml tanezumab injection SC administered every 8 weeks

Placebo IV

Intervention Type BIOLOGICAL

1ml placebo administered IV every 8 weeks

10 mg tanezumab IV

Group Type EXPERIMENTAL

Tanezumab IV

Intervention Type BIOLOGICAL

1 ml tanezumab injection IV administered every 8 weeks

Placebo SC

Intervention Type BIOLOGICAL

1ml placebo administered SC every 8 weeks

Interventions

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Placebo IV

1 ml of placebo administered SC and IV once every 8 weeks.

Intervention Type BIOLOGICAL

Placebo SC

1 ml of placebo administered SC and IV once every 8 weeks.

Intervention Type BIOLOGICAL

Tanezumab SC

1 ml tanezumab injection SC administered every 8 weeks

Intervention Type BIOLOGICAL

Placebo IV

1 ml placebo administered IV every 8 weeks

Intervention Type BIOLOGICAL

Tanezumab SC

1 ml tanezumab injection SC administered every 8 weeks

Intervention Type BIOLOGICAL

Placebo IV

1ml placebo administered IV every 8 weeks

Intervention Type BIOLOGICAL

Tanezumab SC

1 ml tanezumab injection SC administered every 8 weeks

Intervention Type BIOLOGICAL

Placebo IV

1ml placebo administered IV every 8 weeks

Intervention Type BIOLOGICAL

Tanezumab IV

1 ml tanezumab injection IV administered every 8 weeks

Intervention Type BIOLOGICAL

Placebo SC

1ml placebo administered SC every 8 weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of osteoarthritis (OA) of the knee according to American College of Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal to 2
* 18 years of age or greater
* Two methods of birth control one of which must be barrier if of childbearing potential
* Willing to discontinue pain medication except as permitted per protocol

Exclusion Criteria

* Pregnancy or wishing to be pregnant during the course of the study, lactating women
* Body Mass Index (BMI) greater than 39
* Clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol.
* Previous exposure to a Nerve Growth Factor (NGF) antibody
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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Vaughn H. Mancha, Jr., MD, PC

Montgomery, Alabama, United States

Site Status

Novara Clinical Research

Mesa, Arizona, United States

Site Status

Redpoint Research

Phoenix, Arizona, United States

Site Status

Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

West Coast Radiology Center

Anaheim, California, United States

Site Status

Providence Clinical Research

Burbank, California, United States

Site Status

Valley Research

Fresno, California, United States

Site Status

Allergy and Rheumatology Medical Clinic, Inc.

La Jolla, California, United States

Site Status

Triwest Research Associates

La Mesa, California, United States

Site Status

Synergy Clinical Research Center

National City, California, United States

Site Status

Benchmark Research

Sacramento, 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

FMC Clinical Trials

Upland, California, United States

Site Status

Colorado Hematology

Englewood, Colorado, United States

Site Status

Colorado Orthopedic Consultants, P.C.

Englewood, Colorado, United States

Site Status

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status

Office of Cynthia Morgan, MD

Washington D.C., District of Columbia, United States

Site Status

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status

Nature Coast Clinical Research

Crystal River, Florida, United States

Site Status

Fleming Island Center for Clinical Research

Fleming Island, Florida, United States

Site Status

Westside Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

BayCare Outpatient Imaging at Bardmoor

Largo, Florida, United States

Site Status

Sunshine Research Center

Opa-locka, Florida, United States

Site Status

DMI Research, Inc.

Pinellas Park, Florida, United States

Site Status

St. Petersburg Arthritis Center

St. Petersburg, Florida, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

North Georgia Internal Medicine

Woodstock, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Sonoma Clinical Research, LLC.

Boise, Idaho, United States

Site Status

Sonora Clinical Research

Boise, Idaho, United States

Site Status

Apex Medical Research, AMR, Inc.

Chicago, Illinois, United States

Site Status

Professional Research Network of Kansas, LLC

Wichita, Kansas, United States

Site Status

Wichita Clinic PA

Wichita, Kansas, United States

Site Status

Bluegrass Community Research, Inc.

Lexington, Kentucky, United States

Site Status

BenchMark Research

Metairie, Louisiana, United States

Site Status

Arthritis Treatment Center

Frederick, 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

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Ann Arbor Clinical Reserch

Ann Arbor, Michigan, United States

Site Status

Troy Internal Medicine, PC

Troy, Michigan, United States

Site Status

Arthritis Associates, PLLC

Hattiesburg, Mississippi, United States

Site Status

Billings Clinic Infusion Center

Billings, Montana, United States

Site Status

Billings Clinic Research Center

Billings, Montana, United States

Site Status

Physician Research Collaboration, LLC

Lincoln, Nebraska, 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

G. Timothy Kelly, MD

Las Vegas, Nevada, United States

Site Status

Andrew Porges, MD, PC

Roslyn, New York, United States

Site Status

PMG Research of Charlotte

Charlotte, North Carolina, United States

Site Status

Greensboro Imaging

Greensboro, North Carolina, United States

Site Status

Pharmquest

Greensboro, North Carolina, United States

Site Status

Wake Internal Medicine Consultants, Inc.

Raleigh, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Community Research

Cincinnati, Ohio, United States

Site Status

Sterling Research Group, Ltd.

Cincinnati, Ohio, United States

Site Status

LION Research

Norman, Oklahoma, United States

Site Status

McBride Clinic

Norman, Oklahoma, United States

Site Status

Health Research Institute

Oklahoma City, Oklahoma, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Lebanon Internal Medicine Associates

Lebanon, Pennsylvania, United States

Site Status

Founders Research Corporation

Philadelphia, Pennsylvania, United States

Site Status

Clinical Research Center of Reading, LLP

Wyomissing, Pennsylvania, United States

Site Status

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

SoFHA Clinical Research

Johnson City, Tennessee, United States

Site Status

FutureSearch Trials of Neurology

Austin, Texas, United States

Site Status

Tekton Research, Inc.

Austin, Texas, United States

Site Status

Tekton Research, Inc

Austin, Texas, United States

Site Status

Westbury Medical Clinic

Houston, Texas, United States

Site Status

Asif Cochinwala, MD, P.A.

Houston, Texas, United States

Site Status

Accurate Clinical Research

Houston, Texas, United States

Site Status

Mercury Clinical Research

Houston, Texas, United States

Site Status

Pioneer Research Solutions, Inc

Houston, Texas, United States

Site Status

Clinical Trial Network

Houston, Texas, United States

Site Status

Houston Institute for Clinical Research

Houston, Texas, United States

Site Status

Little York Medical Center

Houston, Texas, United States

Site Status

Internist Associates of Texas

Kingwood, Texas, United States

Site Status

Accurate Clinical Research Inc

Nassau Bay, Texas, United States

Site Status

Clinical Investigations of Texas, LLC

Plano, Texas, United States

Site Status

Benchmark Research

San Angelo, Texas, United States

Site Status

Pioneer Research Solutions, Inc

Sugar Land, Texas, United States

Site Status

Grayline Clinical Drug Trials

Wichita Falls, Texas, United States

Site Status

Advanced Clinical Research

West Jordan, Utah, United States

Site Status

Charlottesville Medical Research

Charlottesville, Virginia, United States

Site Status

Hypothe Test, LLC

Roanoke, Virginia, United States

Site Status

Mountain State Clinical Research

Clarksburg, West Virginia, United States

Site Status

Countries

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United States

References

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Brown MT, Cornblath DR, Koltzenburg M, Gorson KC, Hickman A, Pixton GC, Gaitonde P, Viktrup L, West CR. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis. Clin Drug Investig. 2023 Jul;43(7):551-563. doi: 10.1007/s40261-023-01286-3. Epub 2023 Jul 18.

Reference Type DERIVED
PMID: 37460782 (View on PubMed)

Berenbaum F, Schnitzer T, Kivitz A, Viktrup L, Johnston E, Yang R, Whalen E, Tive L, Semel D. Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials. Int J Clin Pract. 2021 Dec;75(12):e14975. doi: 10.1111/ijcp.14975. Epub 2021 Oct 21.

Reference Type DERIVED
PMID: 34626502 (View on PubMed)

Berenbaum F, Schnitzer TJ, Kivitz AJ, Viktrup L, Hickman A, Pixton G, Brown MT, Davignon I, West CR. General Safety and Tolerability of Subcutaneous Tanezumab for Osteoarthritis: A Pooled Analysis of Three Randomized, Placebo-Controlled Trials. Arthritis Care Res (Hoboken). 2022 Jun;74(6):918-928. doi: 10.1002/acr.24637. Epub 2022 Mar 25.

Reference Type DERIVED
PMID: 33973384 (View on PubMed)

Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019.

Reference Type DERIVED
PMID: 30936738 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091027&StudyName=Efficacy%20And%20Safety%20Study%20Of%20Tanezumab%20Subcutaneous%20Administration%20In%20Osteoarthritis%20-%20A%20Subcutaneous/Intravenous%20Bridging%20Study

To obtain contact information for a study center near you, click here.

Other Identifiers

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SC/IV OA STUDY

Identifier Type: OTHER

Identifier Source: secondary_id

A4091027

Identifier Type: -

Identifier Source: org_study_id

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