NCT02697773

Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects With Moderate to Severe Osteoarthritis of the Hip or Knee

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF A DOSE TITRATION REGIMEN FOR THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy of a titration arm of tanezumab in which treatment is started at a lower dose (2.5 mg) and increased to a higher dose (5 mg) at Week 8, compared to giving 2 doses of tanezumab 2.5 mg or 2 doses of placebo. The study also evaluates the safety of the treatment regimens.

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

Type	Name	Description
OTHER	Placebo	Patient receives one dose of placebo to match tanezumab subcutaneously on Day 1 and one dose of placebo to match tanezumab subcutaneously at Week 8.
BIOLOGICAL	Tanezumab 2.5 mg	Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8.
BIOLOGICAL	Tanezumab 2.5mg/5mg	Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.

Timeline

• Start date: 2016-01-21
• Primary completion: 2017-12-05
• Completion: 2018-05-14
• First posted: 2016-03-03
• Last updated: 2021-05-03
• Results posted: 2019-04-23

Locations

87 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study