A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
Phase of Trial: Phase IV
Latest Information Update: 06 Jul 2017
At a glance
- Drugs Tocilizumab (Primary) ; Adalimumab
- Indications Rheumatoid arthritis
- Focus Therapeutic Use
- Acronyms ADACTA
- Sponsors Roche
- 08 Jun 2017 Results assessing liver safety with long-term tocilizumab treatment for rheumatoid arthritis using pooled data (n= 4171) from five core phase 3 placebo-controlled studies (OPTION, TOWARD, LITHE, AMBITION, RADIATE), a clinical pharmacology study (NCT00365001), a phase 4 study (ADACTA) or long-term extension studies, published in the Arthritis and Rheumatology Journal.
- 27 Nov 2015 Results published in the Annals of the Rheumatic Diseases (n = 324).
- 18 Sep 2015 According to a Chugai Pharmaceutical media release, National Institute for Health and Clinical Excellence(NICE) has issued a positive Final Appraisal Determination(FAD) recommending tocilizumab [RoACTEMRA] monotherapy for use on the National Health Services.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History