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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT01412333
• Date of registration: 08/08/2011
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) 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
• Date of first enrolment: September 2011
• Target sample size: 800
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01412333
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

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

Contacts

• Name: Please reference Study ID Number: WA21093 www.roche.com/about_roche/roche_worldwide.htm

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients, 18-55 years of age inclusive

- Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria
(2010)

- At least 2 documented clinical attacks within the last 2 years prior to screening or
one clinical attack in the years prior to screening (but not within 30 days prior to
screening)

- Neurologic stability for >/= 30 days prior to both screening and baseline

- Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

- Primary progressive multiple sclerosis

- Disease duration of more than 10 years in patients with EDSS
- Contraindications for MRI

- Known presence of other neurological disorders which may mimic multiple sclerosis

- Pregnancy or lactation

- Requirement for chronic treatment with systemic corticosteroids or immunosuppressants
during the course of the study

- History of or currently active primary or secondary immunodeficiency

- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies

- Active infection, or history of or known presence of recurrent or chronic infection
(e.g. hepatitis B or C, HIV, syphilis, tuberculosis)

- History of progressive multifocal leukoencephalopathy

- Contraindications to or intolerance of oral or iv corticosteroids

- Contraindications to Rebif or incompatibility with Rebif use



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: ocrelizumab

Drug: ocrelizumab placebo

Drug: Rebif

Drug: Rebif placebo

Primary Outcome(s)

Annualized protocol-defined relapse rate by 2 years in patients with relapsing MS [Time Frame: 96 weeks]

Secondary Outcome(s)

Change in brain volume as detected by brain MRI [Time Frame: from Week 24 to Week 96]

Change in Multiple Sclerosis Functional Composite Scale (MSFCS) score [Time Frame: from baseline to Week 96]

Change in total T2 lesion volume as detected by brain MRI [Time Frame: from baseline to Week 96]

Immunogenicity: Human anti-human antibodies (HAHA) levels [Time Frame: 96 weeks]

Pharmacokinetics: Exposure to ocrelizumab (area under the concentration - time curve) [Time Frame: 96 weeks]

Proportion of relapse-free patients [Time Frame: Week 96]

Safety: Incidence of adverse events [Time Frame: 96 weeks]

Time to onset of sustained disability progression for at least 12 weeks [Time Frame: 96 weeks]

Time to onset of sustained disability progression for at least 24 weeks [Time Frame: 96 weeks]

Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI [Time Frame: 96 weeks]

Secondary ID(s)

WA21093

Source(s) of Monetary Support

Please refer to primary and secondary sponsors