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

NCT02674386

Last updated date
Study Location
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205-1138, United States
Contact
1-800-718-1021

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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Official Title  ICMJE A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Brief Summary 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).
Detailed Description A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Osteoarthritis
Intervention  ICMJE 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.
Study Arms  ICMJE Cohort 1
long-term observational study of subjects from tanezumab parent study
Intervention: Drug: Investigational Medical Product (IMP) administered in parent study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2019)
154
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
250
Actual Study Completion Date  ICMJE July 15, 2019
Actual Primary Completion Date July 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Hungary,   Italy,   Japan,   Lithuania,   New Zealand,   Portugal,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   United States
Removed Location Countries Austria,   Brazil,   Bulgaria,   Colombia,   Croatia,   Finland,   France,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Taiwan,   Ukraine,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02674386
Other Study ID Numbers  ICMJE A4091064
2013-002549-12 ( EudraCT Number )
TJR FOLLOW-UP ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP