Tanezumab and Nerve Function In Arthritis Patients

Summary

Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.

Timeline

Start

2009-05-18

Primary completion

2010-11-16

Completion

2010-11-16

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

registry Tanezumab 5 mg vs Placebo; p = 0.434; Least squares (LS) mean difference 0.29 (95% CI -0.44 to 1.01); ANCOVA NCT00863772 ↗

registry Tanezumab 10 mg vs Placebo; p = 0.883; LS mean difference 0.05 (95% CI -0.68 to 0.79); ANCOVA NCT00863772 ↗

paper Differences in change from baseline to Week 24 in Σ5NC + HRdb were not significant. PMID 25073573 ↗

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.
• Brown MT, Herrmann DN, Goldstein M, Burr AM, Smith MD, West CR, Verburg KM, Dyck PJ. Nerve safety of tanezumab, a nerve growth factor inhibitor for pain treatment. J Neurol Sci. 2014 Oct 15;345(1-2):139-47. doi: 10.1016/j.jns.2014.07.028. Epub 2014 Jul 18.

Drugs

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

Indications