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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: Investigational Medical Product (IMP) administered in parent study

Study type

Interventional

Funder types

Industry

Identifiers

NCT02674386

TJR FOLLOW-UP (Other Identifier)

A4091064

2013-002549-12 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.

Enrollment

154 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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