Tanezumab In Osteoarthritis Of The Knee (2)

Summary

The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.

Timeline

Start

2009-05-05

Primary completion

2010-05-17

Completion

2010-08-31

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo vs Tanezumab 5 mg + Placebo; p <0.001; LS Mean difference -1.24 (95% CI -1.76 to -0.72); ANCOVA NCT00830063 ↗

registry analysis (unspecified test); Placebo vs Tanezumab 5 mg + Placebo; p <0.001; LS mean difference -1.25 (95% CI -1.73 to -0.77); ANCOVA NCT00830063 ↗

registry analysis (unspecified test); Placebo vs Tanezumab 5 mg + Placebo; p <0.001; LS mean difference -0.33 (95% CI -0.50 to -0.16); ANCOVA NCT00830063 ↗

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.
• Ekman EF, Gimbel JS, Bello AE, Smith MD, Keller DS, Annis KM, Brown MT, West CR, Verburg KM. Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen. J Rheumatol. 2014 Nov;41(11):2249-59. doi: 10.3899/jrheum.131294. Epub 2014 Oct 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Naproxen	Small molecule	1000 mg	—
Subject	Tanezumab	Monoclonal antibody	5 mg	Intravenous
Subject	Tanezumab	Monoclonal antibody	10 mg	Intravenous

Indications