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

• Register: EUCTR
• Last refreshed on: 16 November 2020
• Main ID: EUCTR2010-020315-36-IE
• Date of registration: 08/09/2011
• Prospective Registration: Yes
• Primary sponsor: F.Hoffmann-La Roche
• Public title: A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
• Scientific title: 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
• Date of first enrolment: 04/11/2011
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020315-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Double Dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F. Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Male and female patients between ages 18-55 with a diagnosis of
relapsing multiple sclerosis
At least 2 documented clinical attacks within the last 2 years prior to
screening or one clinical attack in the year prior to screening (but not
within 30 days prior to screening)
Patients with EDSS score of 0-5.5
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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use

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
Concentration number: 8.8-22
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

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: equal
Concentration number: 22-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

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: equal
Concentration number: 44-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO4964913
Other descriptive

Primary Outcome(s)

Primary end point(s): Annualized protocol-defined relapse rate at

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.

Main Objective: The primary objective of this study is to assess whether the efficacy of
ocrelizumab 600 mg intravenously every 24 weeks is superior to Rebif®
as measured by the annualized protocol-defined relapse rate by two
years in patients with relapsing multiple sclerosis.

Timepoint(s) of evaluation of this end point: Week 96

Secondary Outcome(s)

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 patients 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 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 patients 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

Secondary ID(s)

2010-020315-36-SK

WA21093

Source(s) of Monetary Support

F. Hoffmann-La Roche AG

Ethics review

Status: Approved
Approval date: 24/10/2011
Contact:

Results

• Results available: Yes
• Date Posted: 03/06/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-020315-36/results