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Trial record 26 of 34 for:    "Osteoarthritis" | ( Map: Japan )

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

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ClinicalTrials.gov Identifier: NCT02674386
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Pfizer

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Investigational Medical Product (IMP) administered in parent study Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Actual Study Start Date : August 23, 2016
Estimated Primary Completion Date : August 12, 2019
Estimated Study Completion Date : August 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cohort 1
long-term observational study of subjects from tanezumab parent study
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.




Primary Outcome Measures :
  1. Surgeon's Assessment of Procedural Difficulty [ Time Frame: Day of Surgery ]
    Percentage of surgeries assessed as uneventful, minor complications or major complications.

  2. Subject's overall satisfaction with surgery as assessed by the Self-Administered Patient Satisfaction (SAPS) Scale [ Time Frame: Week 24 ]
    Percentage of subjects satisfied vs. unsatisfied with their total joint replacement at Week 24

  3. Post-surgical complications [ Time Frame: up to Week 24 ]
    Percentage of subjects with a post-surgical complication(s) up to Week 24.

  4. Additional or Corrective Procedures [ Time Frame: up to Week 24 ]
    Percentage of subjects with additional or corrective procedures related to their total joint replacement up to Week 24.

  5. Physical Rehabilitation Activities [ Time Frame: up to Week 24 ]
    Percentage of subjects participating in physical rehabilitation activities related to the replaced joint up to Week 24.

  6. Average Pain [ Time Frame: Change from baseline to Week 24 ]
    Change from Baseline to Week 24 in average pain in the replaced joint.[Assessed on an 11-point numeric rating scale.]

  7. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Change from baseline to Week 24 ]
    Change from Baseline to Week 24 in WOMAC Pain, Stiffness and Physical Function subscales in the replaced joint (Subjects undergoing total hip or knee replacement surgery only).

  8. Shoulder Pain and Disability Index (SPADI) [ Time Frame: Change from baseline to Week 24 ]
    Change from Baseline to Week 24 in the SPADI in the replaced shoulder (subjects undergoing total shoulder replacement surgery only).

  9. Concomitant Analgesic Use [ Time Frame: Up to Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674386


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Sponsors and Collaborators
Pfizer
Eli Lilly and Company
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02674386     History of Changes
Other Study ID Numbers: A4091064
2013-002549-12 ( EudraCT Number )
TJR FOLLOW-UP ( Other Identifier: Alias Study Number )
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tanezumab
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs