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

• Register: EUCTR
• Last refreshed on: 2 October 2012
• Main ID: EUCTR2010-020315-36-ES
• Date of registration: 21/07/2011
• 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: 18/10/2011
• Target sample size: 800
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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

Countries of recruitment

Argentina, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Colombia, Croatia, Ireland, Italy, Mexico, Peru, Russian Federation, 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

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

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

Relapsing Multiple Sclerosis
MedDRA version: 14.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: ocrelizumab
Product Code: RO4964913
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

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-

Primary Outcome(s)

Secondary Objective: ? To evaluate whether the efficacy of ocrelizumab is superior to Rebif®, as reflected by the following measures:
? The time to onset of sustained disability progression for at least 12 weeks during the 96-week comparative treatment period.
? The time to onset of sustained disability progression for at least 24 weeks during the 96-week comparative treatment period.
? The proportion of relapse-free patients by 96 weeks.
? The change in total T2 lesion volume as detected by brain MRI from baseline to Week 96.
? The total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI at weeks 24, 48 and 96.
? The change in Multiple Sclerosis Functional Composite Scale (MSFCS) score from baseline to Week 96.
? The change in brain volume as detected by brain MRI from Week 24 to Week 96.

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

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

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Assessments will be made at week 24, 48 and 96

Secondary end point(s): ? The time to onset of sustained disability progression.
? The time to onset of sustained disability progression.
? The proportion of relapse-free patients.
? The change in total T2 lesion volume as detected by brain MRI.
? The total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI.
? The change in Multiple Sclerosis Functional Composite Scale (MSFCS) score.
? The change in brain volume as detected by brain MRI.
Additional exploratory endpoint as defined in the protocol

Secondary ID(s)

2010-020315-36-BE

WA21093

Source(s) of Monetary Support

F. Hoffmann-La Roche AG