NCT01089725

Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.

Detailed description

This study was terminated on 08 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Conditions

• Osteoarthritis
• Arthritis
• Pain

Interventions

Type	Name	Description
BIOLOGICAL	Placebo IV	1 ml of placebo administered SC and IV once every 8 weeks.
BIOLOGICAL	Placebo SC	1 ml of placebo administered SC and IV once every 8 weeks.
BIOLOGICAL	Tanezumab SC	1 ml tanezumab injection SC administered every 8 weeks
BIOLOGICAL	Placebo IV	1 ml placebo administered IV every 8 weeks
BIOLOGICAL	Tanezumab SC	1 ml tanezumab injection SC administered every 8 weeks
BIOLOGICAL	Placebo IV	1ml placebo administered IV every 8 weeks
BIOLOGICAL	Tanezumab SC	1 ml tanezumab injection SC administered every 8 weeks
BIOLOGICAL	Placebo IV	1ml placebo administered IV every 8 weeks
BIOLOGICAL	Tanezumab IV	1 ml tanezumab injection IV administered every 8 weeks
BIOLOGICAL	Placebo SC	1ml placebo administered SC every 8 weeks

Timeline

• Start date: 2010-03-30
• Primary completion: 2010-11-08
• Completion: 2011-02-18
• First posted: 2010-03-18
• Last updated: 2021-05-05
• Results posted: 2021-05-05

Locations

91 sites across 1 country: United States