Osteoarthritis of the hip or knee MedDRA version: 20.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10020108 Term: Hips osteoarthritis System Organ Class: 100000004859
Conditions
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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in tanezumab Study A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063 and has completed the study or has been withdrawn from the study. 3.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. 4. Subject is willing and able to comply with scheduled visits and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 137 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 74
Exclusion criteria
Exclusion criteria: Not reported in protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: -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. ; Primary end point(s): -Surgeon’s Assessment of Procedural Difficulty: number and percentage of surgeries assessed as uneventful, minor complications or major complications. -Subject’s overall satisfaction with surgery as assessed by the Self-Administered Patient Satisfaction (SAPS) Scale: number and percentage of subjects satisfied vs. unsatisfied with their total joint replacement at Week 24. -Number and percentage of subjects with a post-surgical complication(s) up to Week 24 (derived from reported adverse events). - Number and percentage of subjects with additional or corrective procedures related to their total joint replacement up to Week 24. - Number and percentage of subjects participating in physical rehabilitation activities related to the replaced joint up to Week 24. -Change from Baseline to Week 24 in average pain in the replaced joint. -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). -Change from Baseline to Week 24 in the SPADI in the replaced shoulder (subjects undergoing total shoulder replacement surgery only). -Concomitant | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Australia, Austria, Brazil, Bulgaria, Colombia, Croatia, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Lithuania, Mexico, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactClinicalTrials.gov call Center
Pfizer Inc
Outcome results
None listed