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

Not Applicable

• Conditions: -G35 Multiple sclerosis; Paratyphoid fever B; Multiple sclerosis; A012; G35

• Registration Number: PER-024-14
• Lead Sponsor: F. Hoffmann- La Roche, Ltd /Genentech Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-08
• Study Completion: 2022-12-31
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

The inclusion criteria are the following:
1.Ability to provide written, informed consent and be able to follow the schedule of protocol assessments *.
2.Ages 18-55 years at screening, inclusive.
3.Diagnosis of MS, in accordance with the revised McDonald criteria (2010).
4.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).
5.Neurological stability for 30 days prior to both screening and baseline.
6.EDSS, at screening, from 0 to 5.5 inclusive.
7.Documented MRI of brain with abnormalities consistent with MS prior to screening.
8.Patients of reproductive potential must use reliable means of contraception as described below as a minimum (adherence to local requirements, if more stringent, is required**):
•For female patients: Two methods of contraception throughout the trial, including the active treatment phase AND for 48 weeks after the last dose of ocrelizumab, or until their B-cells have repleted, whichever is longer.
•For male patients: Two methods of contraception throughout the trial, including the active treatment phase AND for 24 weeks after the last dose of ocrelizumab.

Exclusion Criteria

•Primary progressive multiple sclerosis
•History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
•Chronic treatment with systemic corticosteroids or immunosuppressants, chronic immune system diseases or other conditions that may rule out the involvement of the patient in the study.
•History of progressive multifocal leukoencephalopathy
•Active infection, or history of or known presence of recurrent or chronic infection (e.g. hepatitis B or C, HIV, syphilis, tuberculosis)
•Known presence of other neurological disorders which may mimic multiple sclerosis
•History of or currently active primary or secondary immunodeficiency
•Pregnancy or lactation
•Contraindications to or intolerance of oral or I.V. corticosteroids
•Contraindication to or intolerance of interferon beta-1a (Rebif

Study & Design

• Study Type: Interventional
• Study Design: Not specified