| 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. |
| Interventional |
| Phase 3 |
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other |
| Osteoarthritis |
| 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.
|
| Cohort 1
long-term observational study of subjects from tanezumab parent study
Intervention: Drug: Investigational Medical Product (IMP) administered in parent study
|
| Not Provided |
| |
| Recruiting |
| 250 |
| August 12, 2019 |
| August 12, 2019 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- 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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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.
Exclusion Criteria:
- None.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
|
| Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Croatia, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Lithuania, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States |
| Mexico |
| |
| NCT02674386 |
A4091064
2013-002549-12 ( EudraCT Number )
TJR FOLLOW-UP ( Other Identifier: Alias Study Number ) |
| Yes |
| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
|
| Not Provided |
| Pfizer |
| Pfizer |
| Eli Lilly and Company |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| November 2017 |
