|Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement|
|A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT|
|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).|
|A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.|
|Intervention Model: Single Group Assignment|
Masking: None (Open Label)
Primary Purpose: Other
|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.
long-term observational study of subjects from tanezumab parent study
Intervention: Drug: Investigational Medical Product (IMP) administered in parent study
|July 15, 2019|
|July 15, 2019 (Final data collection date for primary outcome measure)|
- 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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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.
|Sexes Eligible for Study:||All|
|18 Years and older (Adult, Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Australia, Canada, Germany, Hungary, Italy, Japan, Lithuania, New Zealand, Portugal, Russian Federation, Serbia, Slovakia, Spain, Sweden, United States|
|Austria, Brazil, Bulgaria, Colombia, Croatia, Finland, France, Korea, Republic of, Mexico, Peru, Philippines, Poland, Puerto Rico, Romania, Taiwan, Ukraine, United Kingdom|
2013-002549-12 ( EudraCT Number )
TJR FOLLOW-UP ( Other Identifier: Alias Study Number )
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Eli Lilly and Company|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|