A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

Roche

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Biological: Ocrelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02861014

MA30005

2015-005597-38 (EudraCT Number)

Details and patient eligibility

About

The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.

Enrollment: 681 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
• Have a length of disease duration, from first symptom, of less than (<) 10 years
• Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
• Suboptimal disease control while on a DMT
• Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
• For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug

Exclusion criteria

• Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
• Inability to complete an Magnetic Resonance Imaging (MRI) procedure
• Known presence of other neurological disorders
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• History or currently active primary or secondary immunodeficiency
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• History of opportunistic infections
• History or known presence of recurrent or chronic infection
• History of malignancy
• Congestive heart failure
• Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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681 participants in 1 patient group

Ocrelizumab

Experimental group

Description:

Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.

Treatment:

Biological: Ocrelizumab