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: 17 Jan 2018
At a glance
- Drugs Ocrelizumab (Primary) ; Interferon beta-1a
- Indications Multiple sclerosis
- Focus Registrational; Therapeutic Use
- Acronyms OPERA II; ORCHESTRA
- Sponsors Roche
- 12 Jan 2018 According to a Roche media release, based on the data from ORATORIO, OPERA I and OPERA II trial the European Commission (EC) has granted marketing authorisation for OCREVUS (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for patients with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
- 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 700191566), company gained the postitive opinion from the Committee for Medicinal Products for Human Use (CHMP).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History