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

Conditions	Phase	Intervention Type
MS	Phase 3	Drug Rebif Drug ocrelizumab Drug ocrelizumab placebo Drug Rebif placebo

View trial NCT01247324 on www.clinicaltrials.gov

Contacts

Please use the information below to contact the trial coordinators.

Please reference Study ID Number: WA21092

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Eligibility

Ages Eligible for Study: 18 years to 55 years
Genders Eligible for Study: Both

Keywords

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 </= 2.0 at screening

- 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

Detailed Description

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis. Patients will be randomized to receive either in group A, ocrelizumab 600 mg intravenously (iv) every 24 weeks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, Rebif 8.8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc three times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247324

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