Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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2 October 2012 |
Main ID: |
EUCTR2010-020315-36-IT |
Date of registration:
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27/12/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis.
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Scientific title:
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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:
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05/10/2011 |
Target sample size:
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469 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020315-36 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Argentina
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Belarus
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Belgium
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Bosnia and Herzegovina
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Brazil
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Canada
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Colombia
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Croatia
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Ireland
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Italy
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Mexico
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Peru
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Russian Federation
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Spain
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Sweden
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Operations Italy
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Address:
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Viale G.B. Stucchi, 110
20900
Monza (MB)
Italy |
Telephone:
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+39 039 247 5070 |
Email:
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sergio.scaccabarozzi@roche.com |
Affiliation:
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Roche S.p.A. |
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Name:
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Clinical Operations Italy
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Address:
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Viale G.B. Stucchi, 110
20900
Monza (MB)
Italy |
Telephone:
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+39 039 247 5070 |
Email:
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sergio.scaccabarozzi@roche.com |
Affiliation:
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Roche S.p.A. |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Relapsing Multiple Sclerosis MedDRA version: 14.1
Level: PT
Classification code 10063399
Term: Relapsing-remitting multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
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Intervention(s)
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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 milligram(s) Concentration type: equal Concentration number: 200- 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- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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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.
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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.
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Timepoint(s) of evaluation of this end point: 96 weeks
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Primary end point(s): Annualized protocol-defined relapse rate at
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Assessments will be made at week 24, 48 and 96.
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Secondary end point(s): • 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. Et al...
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Secondary ID(s)
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WA21093
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2010-020315-36-BE
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Source(s) of Monetary Support
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F. Hoffmann-La Roche AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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