A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

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 - OPERA II

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020315-36-SK

Enrollment

800

Registered

2011-06-28

Start date

2011-10-18

Completion date

Unknown

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Rebif Pharmaceutical Form: Solution for injection INN or Proposed INN: INTERFERON BETA-1A CAS Number: 220581-49-7 Concentration unit: µg microgram(s) Concentration type: range Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female participants between ages 18-55 with a diagnosis of relapsing multiple sclerosis At least 2 documented clinical attacks within the last 2 years before screening or one clinical attack in the year before screening (but not within 30 days before screening) Patients with EDSS score of 0-5.5, at Screening Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Patients with other chronic disease of the immune system, malignancies or other diseases or conditions that could preclude patient from participating in the study Contraindications to or intolerance of oral or i.v. corticosteroids Contraindication to or intolerance of interferon beta-1a (Rebif) Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to assess whether the efficacy of ocrelizumab 600 mg every 24 weeks is superior to Rebif® as measured by protocol-defined ARR during nearly 2 years in participants with relapsing multiple sclerosis (RMS). ;Secondary Objective: To evaluate whether the efficacy of ocrelizumab is superior to Rebif®, as reflected by the following measures: • The time to onset of confirmed disability progression for at least 12 weeks with the initial event of neurological worsening occurring during the 96-week, double-blind, double-dummy, treatment period. • The total number of T1 Gd-enhancing lesions as detected by brain MRI at weeks 24, 48 and 96 • The total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI at Weeks 24, 48, and 96. • The proportion of patients who have confirmed disability improvement for at least 12 weeks initial event of neurological improvement occurring during the 96-week, double-blind, double-dummy, treatment period. • The time to onset of confirmed disability progression for at least 24 weeks with the initial event of neurological worsening ocurring during the 96-week, double-blind, double-dummy, treatment period. See Section 2.2 of the protocol for full list;Primary end point(s): Annualized protocol-defined relapse rate at ;Timepoint(s) of evaluation of this end point: Week 96	—

Measure

Time frame

Main Objective: The primary objective of this study is to assess whether the efficacy of ocrelizumab 600 mg every 24 weeks is superior to Rebif® as measured by protocol-defined ARR during nearly 2 years in participants with relapsing multiple sclerosis (RMS). ;Secondary Objective: To evaluate whether the efficacy of ocrelizumab is superior to Rebif®, as reflected by the following measures: • The time to onset of confirmed disability progression for at least 12 weeks with the initial event of neurological worsening occurring during the 96-week, double-blind, double-dummy, treatment period. • The total number of T1 Gd-enhancing lesions as detected by brain MRI at weeks 24, 48 and 96 • The total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI at Weeks 24, 48, and 96. • The proportion of patients who have confirmed disability improvement for at least 12 weeks initial event of neurological improvement occurring during the 96-week, double-blind, double-dummy, treatment period. • The time to onset of confirmed disability progression for at least 24 weeks with the initial event of neurological worsening ocurring during the 96-week, double-blind, double-dummy, treatment period. See Section 2.2 of the protocol for full list;Primary end point(s): Annualized protocol-defined relapse rate at ;Timepoint(s) of evaluation of this end point: Week 96

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Secondary

Measure	Time frame
Secondary end point(s): 1. The time to onset of confirmed disability progression for at least 12 weeks with the initial event of neurological worsening occurring during the 96-week, double-blind, double-dummy, treatment period 2. The total number of T1 Gd-enhancing lesions as detected by brain MRI 3. The total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI 4. The proportion of participants who have confirmed disability improvement for at least 12 weeks, with the initial event of neurological improvement occurring during the 96-week double-blind, double-dummy treatment period. 5. The time to onset of confirmed disability progression for at least 24 weeks with the initial event of neurological worsening occurring during the 96-week, double-blind, double-dummy, treatment period 6. The total number of new T1-hypo-intense lesions (chronic black holes) 7. The change in MSFCS score 8. The percentage change in brain volume as detected by brain MRI 9. The change in SF-36 PCS Score 10. The proportion of participants who have NEDA Additional exploratory endpoints as defined in the protocol;Timepoint(s) of evaluation of this end point: 1. Assessed throughout the study 2. At Weeks 24, 48, and 96 3. At Weeks 24, 48, and 96. 4. Assessed throughout the study 5. Assessed throughout the study 6. At Weeks 24, 48, and 96 7. Baseline to Week 96 8. From Week 24 to Week 96. 9. Baseline to Week 96 10. By Week 96	—

Measure

Time frame

Secondary end point(s): 1. The time to onset of confirmed disability progression for at least 12 weeks with the initial event of neurological worsening occurring during the 96-week, double-blind, double-dummy, treatment period 2. The total number of T1 Gd-enhancing lesions as detected by brain MRI 3. The total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI 4. The proportion of participants who have confirmed disability improvement for at least 12 weeks, with the initial event of neurological improvement occurring during the 96-week double-blind, double-dummy treatment period. 5. The time to onset of confirmed disability progression for at least 24 weeks with the initial event of neurological worsening occurring during the 96-week, double-blind, double-dummy, treatment period 6. The total number of new T1-hypo-intense lesions (chronic black holes) 7. The change in MSFCS score 8. The percentage change in brain volume as detected by brain MRI 9. The change in SF-36 PCS Score 10. The proportion of participants who have NEDA Additional exploratory endpoints as defined in the protocol;Timepoint(s) of evaluation of this end point: 1. Assessed throughout the study 2. At Weeks 24, 48, and 96 3. At Weeks 24, 48, and 96. 4. Assessed throughout the study 5. Assessed throughout the study 6. At Weeks 24, 48, and 96 7. Baseline to Week 96 8. From Week 24 to Week 96. 9. Baseline to Week 96 10. By Week 96

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Countries

Argentina, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, France, Germany, Ireland, Italy, Mexico, Peru, Russian Federation, Slovakia, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026