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

Principal Investigator

Kottil Rammohan

Enrollment Status

Closed

Clinical Trial ID

Institutional Protocol # 20110636
National Clinical Trials Identifier NCT01412333

Clinical Trial Summary


Phase

Phase 3


Funding Agency/Sponsor

Industry


Disease

Other


Enrollment Eligibility

Inclusion Criteria:
- 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 greater than or equal to (>/=) 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 score less than or equal
to (- 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
(for example, hepatitis B or C, Human Immunodeficiency Virus [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


Contact Information

Study Contact Neurology Research
Phone Number 1-877-977-7724
Get detailed information on ClinicalTrials.Gov