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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Arthritis, Pain

In brief

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.

Key facts

Study ID

NCT01089725

Run by

Pfizer

People needed

385

Starts

2010-03-30

Expected to finish

2011-02-18

Last updated by the study team

2021-05-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novara Clinical Research — Mesa, Arizona, United States
• Redpoint Research — Phoenix, Arizona, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• West Coast Radiology Center — Anaheim, California, United States
• Providence Clinical Research — Burbank, California, United States
• Valley Research — Fresno, California, United States
• Allergy and Rheumatology Medical Clinic, Inc. — La Jolla, California, United States
• Triwest Research Associates — La Mesa, California, United States
• Synergy Clinical Research Center — National City, California, United States
• Benchmark Research — Sacramento, California, United States
• Probe Clinical Research Corp. — Santa Ana, California, United States
• Trinity Clinical Trials — Santa Ana, California, United States
• FMC Clinical Trials — Upland, California, United States
• Colorado Hematology — Englewood, Colorado, United States
• Colorado Orthopedic Consultants, P.C. — Englewood, Colorado, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Office of Cynthia Morgan, MD — Washington D.C., District of Columbia, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Nature Coast Clinical Research — Crystal River, Florida, United States
• Fleming Island Center for Clinical Research — Fleming Island, Florida, United States
• Westside Center for Clinical Research — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• BayCare Outpatient Imaging at Bardmoor — Largo, Florida, United States
• Sunshine Research Center — Opa-locka, Florida, United States
• Vaughn H. Mancha, Jr., MD, PC — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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