Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Summary
The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.
Timeline
- Start
- 2009-02-12
- Primary completion
- 2010-10-28
- Completion
- 2011-01-12
Outcome
Mixed primary results
Stopped: “See termination reason in detailed description.”
registry analysis (unspecified test); Tanezumab 10 mg + Naproxen 500 mg vs Naproxen 500 mg; p <0.001; LS Mean Difference -0.88 (95% CI -1.23 to -0.53); ANCOVA NCT00809354 ↗
registry analysis (unspecified test); Tanezumab 5 mg + Naproxen 500 mg vs Naproxen 500 mg; p = 0.251; LS Mean Difference -0.08 (95% CI -0.22 to 0.06); ANCOVA NCT00809354 ↗
paper Although all tanezumab treatments provided significant improvements in WOMAC Pain and Physical Function over either NSAID alone, only tanezumab+NSAIDs were significant versus NSAIDs with PGA and met the prespecified definition of superiority. PMID 24625625 ↗
Publications
- Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019.
- Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
- Schnitzer TJ, Ekman EF, Spierings EL, Greenberg HS, Smith MD, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Ann Rheum Dis. 2015 Jun;74(6):1202-11. doi: 10.1136/annrheumdis-2013-204905. Epub 2014 Mar 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Celecoxib | Other / unclassified | 100 mg | Oral |
| Subject | Naproxen | Small molecule | 500 mg | Oral |
| Subject | Tanezumab | Monoclonal antibody | 5 mg | Intravenous |
| Subject | Tanezumab | Monoclonal antibody | 10 mg | Intravenous |