TANGO
A phase 3 randomised, double-blind, placebo-controlled, multicentre study of the analgesic efficacy and safety of the subcutaneous administration of tanezumab in subjects with osteoarthritis of the hip or knee
This is a randomized, double‑blind, placebo‑controlled, parallel‑group multicenter study of the efficacy and safety of tanezumab when administered by SC injection for 24 weeks compared to placebo in subjects with osteoarthritis of the knee or hip.
The study is designed with a total post-randomization duration of 48 weeks and will consist of three periods: Screening (up to 37 days), Double-blind Treatment (24 weeks) and Safety Follow-up (24 weeks). The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24, with the secondary one of evaluating safety of tanezumab at those doses.
Chief Investigator: Dr Philip Riches
Number and location of participating sites (by region/ country): International multicentre trial approx. 810 patients
EudraCT number: 2013-004508-21
Funder: Pfizer
Start and End date of grant award: Sep 2016 -Sep 2018
Current Status: Completed
Trial Unblinding Information: Available
Contact Information / Sponsor: Pfizer
Dr David Walker, Pfizer Inc.
Clinical Team: Debbie Alexander and Morag Charles
ECTU Involvement: Clinical support – research nurses