Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee, Osteoarthritis, Hip

In brief

The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens.

Key facts

Study ID

NCT02697773

Run by

Pfizer

People needed

698

Starts

2016-01-21

Expected to finish

2018-05-14

Last updated by the study team

2021-05-03

Who can join

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

You may qualify if…

• Diagnosis of Osteoarthritis of the knee or hip confirmed by X-ray
• Documented history that subject tried the following medications and had insufficient pain relief or is cannot take or tolerate them: acetaminophen, NSAIDs and either tramadol or opioids
• Meet the protocol requirements for pain at screening and pain, physical function and patient global assessment of osteoarthritis at baseline
• Willing to discontinue all pain medications except study medication and rescue medication during the course of the study and use those as directed per protocol
• Women able to have children must agree to use 2 forms of contraception during the study

You may not qualify if…

• Body Mass Index (BMI) greater than 39
• History of diseases other than osteoarthritis in a shoulder, hip or knee (example, rheumatoid arthritis, gout, joint infections, osteonecrosis)
• Patients with x-ray showing joint conditions such as osteonecrosis (dead bone) or certain types of fractures
• Patients who have had significant trauma or surgery to a knee, hip or shoulder within the previous year
• Planned surgical procedure during the study
• Patients who are largely or wholly incapacitated (example bedridden or confined to a wheelchair, permitting little or no self-care)
• Patients who would be unwilling or unable to undergo joint replacement surgery if one eventually became necessary
• Patients with significant conditions other than osteoarthritis that could interfere with assessment of pain in the joints (example fibromyalgia, lupus erythematosus)
• Patients with significant heart, neurological or psychiatric diseases
• Patients who had cancer other than certain skin cancers within the past 5 years
• Patients with alcohol, analgesic (pain medications) or drug abuse within the past 2 years
• Women who are pregnant, breast-feeding or intending to become pregnant or breast-feed during the course of the study.

Where it is running

• Cahaba Research, Inc. — Birmingham, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Clinical Research Institute of Arizona, LLC — Surprise, Arizona, United States
• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• University of Arizona Clinical and Translational Science Research Center — Tucson, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• Advanced Research Center, Inc — Anaheim, California, United States
• Medvin Clinical Research — Covina, California, United States
• St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
• Irvine Center for Clinical Research — Irvine, California, United States
• Robert L Freed, M.D., F.A.C.R / Clinical Interventions Research Institute — Irvine, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• California Research Foundation — San Diego, California, United States
• Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• New England Research Associates, LLC — Bridgeport, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• Eastern Research, Inc. — Hialeah, Florida, United States
• South Florida Research Center, Inc. — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Miami Dade Medical Research Institute, LLC — Miami, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Alabama Orthopaedic Surgeons — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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