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Submitted by: Ms. Karen Solis 2016-03-10 00:00:00 Last Updated by: Ms. Karen Solis 2019-07-17 07:33:28


A Phase 3, Multicenter, Long-Term Observational Study Of Subjects From Tanezumab Studies Who Undergo A Total Knee, Hip or Shoulder Replacement

PHRR160322-001198

A4090164

2015-CT0304

A Phase 3, Multicenter, Long-Term Observational Study Of Subjects From Tanezumab Studies Who Undergo A Total Knee, Hip or Shoulder Replacement

This is a Phase 3, multicenter, long-term observational study of subjects from tanezumab Study A4091056, A4091057 or A4091058 (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study (treatment period or safety follow-up period). If while the subject is participating in this study (A4091064), the subject undergoes an additional total joint replacement surgery or the site becomes aware that an additional total joint replacement surgery has been scheduled for the subject, the subject will be requested to provide information on the additional total joint replacement surgery as well. Finally, any subject with a qualifying total joint replacement after the last subject in the study completes the treatment period in studies A4091059, A4091061 or A4091063 may be followed in this study (A4091064).
 
This 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 (IWRS) accessed by desktop, laptop or tablet computer (or paper if the subject has no access to the internet via a desktop, laptop or tablet computer). Following the surgery, the subject will be contacted monthly via telephone by study site personnel to ascertain whether the subject has experienced any adverse events and to record any concomitant analgesic medications the subject is taking as well as the reason for the medication use. An assessment of the subject’s overall satisfaction with their total joint replacement (IWRS), average pain in the replaced joint (IWRS), the subject’s level of function and activity in the replaced joint (IWRS) and physical rehabilitation activities (telephone interview) will be made at Weeks 4, 12 and 24. At Weeks 12 and 24, subjects will be queried during the telephone interview as to whether any additional or corrective procedures related to the total joint replacement are planned.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-07-01 6 2019-01-01 0000-00-00

Completed

Institution Classification Region LTO #
Pfizer Inc. Private Business NCR N/A
Institution Classification Region LTO #
inVentiv Health Philippines Inc. Private Business NCR CDRR-NCR-CRO-5
Institution Region
Pfizer Inc. - USA United States of America
Name E-Mail Institution and Institution Address
Cesar Brence Labastida CesarBrence.Labastida@pfizer.com 23/F Ayala Life-FGU Center 6811 Ayala Avenue, Makati City 1200 Philippines
Name E-Mail Institution and Institution Address
ClinicalTrials.gov call Center clinicaltrials.govcallcenter@pfizer.com Pfizer Inc, 235 East 42nd Street, New York, NY 10017, US
Name Expertise Affiliation
Bernadette Heizel Manapat-Reyes, MD Principal Investigator Philippine General Hospital
Eric Jason Amante, MD Principal Investigator Manila Doctors Hospital
Joseph M. Antigua, MD principal investigator Chong Hua Hospital
Project Location Institutional Ethics Review Board
Philippine General Hospital Philippine General Hospital Ethics Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Chong Hua Hospital Chong Hua Hospital Institutional Review Board

osteoarthritis

The primary objective of this study is to describe the post-operative outcome of subjects who underwent a total knee, hip, or shoulder replacement while participating in tanezumab Study A4091056, A4091057 or A4091058 (treatment period and safety follow-up period).

Secondary objectives are:

- To compare the post-operative outcome for tanezumab 2.5 mg and 5 mg versus NSAID for subjects who underwent a total knee, hip, or shoulder replacement while participating in tanezumab Study A4091058.

- To describe the post-operative outcome of subjects from the A4091059, A4091061 or A4091063 studies who underwent a total knee, hip, or shoulder replacement

Pending

  • Philippines

Clinical Trial

A4090164

2015-CT0304

2015-10-23

0000-00-00

Unspecified

Unspecified

Unspecified

01 Jul 2018

4.1. Inclusion Criteria
 
Subject eligibility should be reviewed and documented by an appropriate member of the investigator’s study team before subjects are included in the study. Appropriate members of the investigator's study team are the investigator or sub-investigator.
 
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
 
1.  Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2.  Subject has been randomized and treated with SC investigational product in tanezumab Study A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063 and has completed the study or has been withdrawn from the study.
3.  Actual or planned total knee, hip or shoulder replacement surgery during tanezumab Study A4091056, A4091057 or A4091058 or after the last subject in the study completes the treatment period in tanezumab Study A4091059, A4091061 or A4091063. Note: additional procedures in a subject undergoing total joint replacement surgery (eg, revision of a previously replaced joint in addition to a new total joint replacement) will be allowed, but subjects undergoing solely sub-total arthroplastic procedures (eg, hemi-arthroplasty) will not be eligible.
4.  Subject is willing and able to comply with scheduled visits and other study procedures.

Observational

Unspecified

Unspecified

None

Unspecified

Unspecified

Unspecified

Not Applicable

There are no protocol defined study medications in this observational study. 

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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