None listed
Conditions
Interventions
1. SC placebo (to match tanezumab) once every 8 weeks (a total of 7 administrations) plus NSAID administered orally (PO) (naproxen 500 mg BID PO, celecoxib 100 mg BID PO, or diclofenac ER 75 mg BID PO
Sponsors
PFIZER S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject eligibility should be reviewed and documented by an appropriate member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. Male or female of any race, ≥18 years of age. 3. A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence42 X-ray Grade of ≥2 as diagnosed by the Central Reader; Appendix 1). Additional information, please see the protocol.
Exclusion criteria
Exclusion criteria: Subjects with any of the following characteristics/conditions will not be included in the study: 1. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study. 2. Body Mass Index (BMI) of >39 kg/m2. For subjects requiring DXA scan (refer to Section 7.3.12) body weight 300 lbs is exclusionary. 3. History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, joint infections, Paget’s disease, or tumors. Additional information, please see the protocol.
Countries
Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Hungary, Italy, Japan, Korea South, Mexico, New Zealand, Peru, Philippines, Poland, Russian Federation, Spain, Taiwan
Contacts
Public ContactCarla Olivera
PFIZER S.A.
Outcome results
None listed