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

PFIZER S.A.,0 个研究点目标入组 37 人开始时间: 2016年4月7日最近更新: 2023年9月4日

适应症

试验速览

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•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.

•Subjects with any of the following characteristics/conditions will not be included in the
•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.

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