A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 22 Nov 2017
At a glance
- Drugs Ocrelizumab (Primary) ; Interferon beta-1a
- Indications Multiple sclerosis
- Focus Registrational; Therapeutic Use
- Acronyms OPERA I
- Sponsors Roche
- 10 Nov 2017 According to a Roche media release, final decision regarding approval of OCREVUS from the European Commission is expected in the coming months following which marketing authorisation for OCREVUS will be granted in all 28 member states of the European Union.
- 10 Nov 2017 According to a Roche media release, based on the data from this and other two studies (700059235 and 700204506), company gained the postitive opinion from the Committee for Medicinal Products for Human Use (CHMP).
- 28 Oct 2017 Results (n=7) assessing ability of T cells to elicit polyfunctional cytokine responses, presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History