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Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

NCT02528188•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader
•Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period
•WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening
•Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study
•Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements

Exclusion Criteria

•Subjects exceeding protocol defined BMI or body weight limits
•History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments
•Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer
•A history of osteonecrosis or osteoporotic fracture
•History of significant trauma or surgery to a knee, hip or shoulder within the previous year
•Planned surgical procedure during the duration of the study
•Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain
•Signs or symptoms of carpal tunnel syndrome in the year prior to Screening
•Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
•Contraindications to magnetic resonance imaging
+20 more criteria

Locations (507)

Central Alabama Research

Birmingham, Alabama, United States

Achieve Clinical Research, LLC

Birmingham, Alabama, United States

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Alabama Orthopaedic Surgeons

Birmingham, Alabama, United States

Rheumatology Associates of North Alabama, PC

Huntsville, Alabama, United States

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Ferguson Family Medicine

Mesa, Arizona, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Valley Pain Consultants

Scottsdale, Arizona, United States

Key Dates

Start Date

July 21, 2015

Primary Completion Date

October 5, 2018

Completion Date

February 27, 2019

Last Updated

January 10, 2020

Enrollment

3,021

ACTUAL participants

Conditions

Chronic PainOsteoarthritis, HipOsteoarthritis, Knee

Interventions

NSAID

DRUG

Tanezumab 2.5 mg

BIOLOGICAL

Tanezumab 5 mg

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee

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Exclusion Criteria

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