Authors
TJ Schnitzer, NE Lane, C Birbara, MD Smith, SL Simpson, MT Brown
Publication date
2011/6/1
Journal
Osteoarthritis and Cartilage
Volume
19
Issue
6
Pages
639-646
Publisher
WB Saunders
Description
OBJECTIVE
This study was designed to evaluate the long-term safety and effectiveness of repeated doses of the humanized anti-nerve growth factor antibody, tanezumab, during open-label treatment of patients with OA knee pain.
DESIGN
The current study (clinicaltrials.gov identifier: NCT00399490) was a multicenter, phase II, open-label, multiple-dose extension of an earlier randomized clinical trial. All patients (N=281) received infusions of tanezumab 50μg/kg on Days 1 and 56 with subsequent doses administered at 8-week intervals (up to a total of eight infusions). The primary endpoint of this study was safety. Effectiveness evaluations included overall knee pain, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index subscales, and subject global assessment (SGA) of response to therapy on 0–100 point visual analog scales.
RESULTS
Repeated administration of tanezumab resulted in a …
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Scholar articles
TJ Schnitzer, NE Lane, C Birbara, MD Smith… - Osteoarthritis and Cartilage, 2011