Relapsing multiple sclerosis (RMS) study design: OPERA I and II 1

Identical, robust, head-to-head clinical trials

The efficacy and safety of OCREVUS in RMS were studied vs Rebif in 2 double-blind, double-dummy trials evaluating over 1600 patients for 2 years.

Opera I and II Identical Study Design 1

OCREVUS: OPERA I, n=410; OPERA II, n=417
Rebif: OPERA I, n=411; OPERA II, n=418

Patients receiving OCREVUS were given a 600 mg IV dose every 6 months (Dose 1 administered as two 300 mg IV infusions 2 weeks apart) and placebo subcutaneous injections 3 times a week. Patients receiving Rebif® (interferon β-1a) were given 44 µg subcutaneous injections 3 times per week and placebo IV infusions every 6 months. Additional endpoints studied included proportion of patients with confirmed disability improvement and mean number of new T1 hypointense lesions (chronic black holes) per MRI. 

Gd+=gadolinium-enhancing; EDSS=Expanded Disability Status Scale.

Well-balanced studies of RMS patients

RMS Patient Demographics 1,2
RMS patient demographics for OPERA 1 & 2 clinical trials.

DMT=disease-modifying therapy.

% of patients who completed the trials OPERA 1 89% OCREVUS vs 83% Rebif, OPERA 2 86% OCREVUS vs 77% Rebif.
Proven in RMS

OCREVUS was proven in RMS across key clinical and MRI measures of efficacy.