Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
NCT02674386
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Personally signed and dated informed consent document.
- Randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.
- Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study.
- Willing and able to comply with scheduled visits and other study procedures.
- None.
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Descriptive Information | |||||||
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Brief Title ICMJE | Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement | ||||||
Official Title ICMJE | A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT | ||||||
Brief Summary | A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet). | ||||||
Detailed Description | A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other | ||||||
Condition ICMJE | Osteoarthritis | ||||||
Intervention ICMJE | Drug: Investigational Medical Product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study. | ||||||
Study Arms ICMJE | Cohort 1
long-term observational study of subjects from tanezumab parent study Intervention: Drug: Investigational Medical Product (IMP) administered in parent study | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 154 | ||||||
Original Estimated Enrollment ICMJE | 250 | ||||||
Actual Study Completion Date ICMJE | July 15, 2019 | ||||||
Actual Primary Completion Date | July 15, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - None. | ||||||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Canada, Germany, Hungary, Italy, Japan, Lithuania, New Zealand, Portugal, Russian Federation, Serbia, Slovakia, Spain, Sweden, United States | ||||||
Removed Location Countries | Austria, Brazil, Bulgaria, Colombia, Croatia, Finland, France, Korea, Republic of, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Taiwan, Ukraine, United Kingdom | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02674386 | ||||||
Other Study ID Numbers ICMJE | A4091064 2013-002549-12 ( EudraCT Number ) TJR FOLLOW-UP ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Eli Lilly and Company | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | July 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |