A Study of Tanezumab in Adults With Chronic Low Back Pain

Summary

The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.

Timeline

Start

2009-06-15

Primary completion

2010-06-16

Completion

2011-02-01

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo vs Tanezumab 10 mg; p <0.001; LS Mean Difference -0.80 (95% CI -1.19 to -0.42); ANCOVA NCT00876187 ↗

paper Tanezumab 10 and 20mg had similar efficacy profiles and significantly improved LBPI, Roland Morris Disability Questionnaire, and PGA scores vs both placebo and naproxen (P⩽.05). PMID 23628600 ↗

Publications

• 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.
• Kivitz AJ, Gimbel JS, Bramson C, Nemeth MA, Keller DS, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. Pain. 2013 Jul;154(7):1009-21. doi: 10.1016/j.pain.2013.03.006. Epub 2013 Mar 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Naproxen	Small molecule	500 mg	Oral
Subject	Tanezumab	Monoclonal antibody	5 mg	Intravenous
Subject	Tanezumab	Monoclonal antibody	10 mg	Intravenous
Subject	Tanezumab	Monoclonal antibody	20 mg	Intravenous

Indications

No indication recorded.