Tanezumab in Osteoarthritis of the Knee

Summary

Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.

Timeline

Start

2008-09-15

Primary completion

2009-08-24

Completion

2010-01-14

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo vs Tanezumab 5 mg; p <0.001; LS Mean Difference -0.98 (95% CI -1.54 to -0.41); ANCOVA NCT00733902 ↗

registry analysis (unspecified test); Placebo vs Tanezumab 10 mg; p <0.001; LS Mean Difference -1.24 (95% CI -1.80 to -0.68); ANCOVA NCT00733902 ↗

Publications

• Brown MT, Cornblath DR, Koltzenburg M, Gorson KC, Hickman A, Pixton GC, Gaitonde P, Viktrup L, West CR. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis. Clin Drug Investig. 2023 Jul;43(7):551-563. doi: 10.1007/s40261-023-01286-3. Epub 2023 Jul 18.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tanezumab	Monoclonal antibody	2.5 mg	Intravenous
Subject	Tanezumab	Monoclonal antibody	5 mg	Intravenous
Subject	Tanezumab	Monoclonal antibody	10 mg	Intravenous

Indications