A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections

Stopped early · Phase 2

Conditions studied: Osteoarthritis, Knee, Osteoarthritis, Hip

In brief

This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.

Key facts

Study ID

NCT00994890

Run by

Pfizer

People needed

679

Starts

2009-11-17

Expected to finish

2011-03-01

Last updated by the study team

2021-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);

You may not qualify if…

• Body mass index (BMI) of >39 kg/m2;
• Pregnancy or intent to become pregnant
• Planned surgical procedure during the duration of the study
• History of clinically significant cardiovascular, central nervous system or psychiatric disease
• Previous exposure to exogenous NGF or to an anti NGF antibody;
• Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions

Where it is running

• Seton Medical Management, Inc. — Mobile, Alabama, United States
• Phoenix Rheumatology Specialists, Ltd. — Phoenix, Arizona, United States
• Radiant Research, Inc — Scottsdale, Arizona, United States
• Advanced Arthritis Care and Research — Scottsdale, Arizona, United States
• Catalina Pointe Clinical Research, Inc — Tucson, Arizona, United States
• Ft. Smith Rheumatology, PC — Fort Smith, Arkansas, United States
• Larry Watkins, MD — Little Rock, Arkansas, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• OrthoArkansas, PA — Little Rock, Arkansas, United States
• Radiology Consultants — Little Rock, Arkansas, United States
• Medvin Clinical Research — Covina, California, United States
• Pacific Arthritis Care Center — Los Angeles, California, United States
• Staywell Research — Northridge, California, United States
• University Imaging Centers — Northridge, California, United States
• C Michael Neuwelt, MD — San Leandro, California, United States
• Pacific Arthritis Center Medical Group — Santa Maria, California, United States
• Medvin Clinical Research — Whittier, California, United States
• RASF Clinical Research Center — Boca Raton, Florida, United States
• Sunrise Medical Research — Lauderdale Lake, Florida, United States
• Melbourne Internal Medicine Associates — Melbourne, Florida, United States
• MIMA Century Research Associate — Melbourne, Florida, United States
• Osler Medical, Inc. — Melbourne, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• American Family Medical — Ocala, Florida, United States
• Mobile Diagnostic Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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