Phase 3
N=154
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02674386 ↗Enrolled (actual)
154
Serious AEs
11.9%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Surgeon's Assessment of Procedural Difficulty — 9; 49; 8; 66 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Investigational Medical Product (IMP) administered in parent study (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Surgeon's Assessment of Procedural Difficulty |
9; 49; 8; 66; 0; 2 | — |
| PRIMARY Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 |
9; 53; 5; 67; 0; 5 | — |
| PRIMARY Number of Participants With Post-Surgical Complications Upto Week 24 |
0; 1; 0; 1; 0; 5 | — |
| PRIMARY Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 |
0; 4; 0; 4; 0; 5 | — |
| PRIMARY Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 |
10; 55; 7; 72; 9; 33 | — |
| PRIMARY Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 |
6.00; 6.86; 6.80; 6.76; 6.10; 6.81 | — |
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 |
4.66; 5.62; 6.11; 5.56; 4.80; 5.97 | — |
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 |
4.80; 5.75; 6.44; 5.71; 4.70; 5.96 | — |
| PRIMARY Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 |
4.83; 5.82; 6.63; 5.79; 5.56; 6.50 | — |
| PRIMARY Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 |
89.88; 89.88; -89.88; -89.88 | — |
| PRIMARY Number of Participants Who Used Concomitant Analgesic Medications |
18; 100; 15; 133 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02674386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.