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| 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 |
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| Completed |
| 154 |
| 250 |
| July 15, 2019 |
| July 15, 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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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 |
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| 18 Years and older (Adult, Older Adult) |
| No |
| 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 |
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| 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 |
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| Pfizer |
| Pfizer |
| Eli Lilly and Company |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
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| Pfizer |
| July 2019 |
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