A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Study of MRA-SC in Patients with Takayasu Arteritis
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 25 Aug 2017
At a glance
- Drugs Tocilizumab (Primary)
- Indications Takayasu syndrome
- Focus Therapeutic Use
- Sponsors Chugai Pharmaceutical
- 25 Aug 2017 According to a Chugai Pharmaceuticals media release, based on the results from this and the GiACTA study,the company obtained an approval Actemra 162mg Syringe for subcutaneous (SC) Injection and Actemra 162mg Auto-Injector for SC Injection by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional indications of Takayasu arteritis (TAK) and giant cell arteritis (GCA) that have not responded sufficiently to existing therapies.
- 07 Apr 2017 Planned End Date changed from 1 Feb 2017 to 1 Dec 2017.
- 30 Nov 2016 According to a Chugai Pharmaceutical media release, based on the results from this and GiACTA study, the company has filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of an additional indication of large vessel vasculitis (LVV) for the humanized anti-human IL-6 receptor monoclonal antibody, Actemra.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History