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Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

Last updated on August 21, 2018

FOR MORE INFORMATION
Study Location
Central Alabama Research
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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and has completed the study or been withdrawn from the study.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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- None.

NCT02674386
Pfizer
Recruiting
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

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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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
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

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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