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

Not Applicable

Recruiting

• Conditions: -M05; M05

• Registration Number: PER-069-15
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-07
• Study Completion: 2019-02-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 37

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified