A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1225

Inclusion Criteria

- Able to comply with the study protocol, in the investigator’s judgment
- Age 18 - 55 years, inclusive
- Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
- Have a length of disease duration, from first documented clinical attack consistent with multiple sclerosis (MS) disease of <= 3 years
- Within the last 12 months: one or more clinically reported relapse(s) or one or more signs of MRI activity
- Expanded Disability Status Scale (EDSS) of 0.0 to 3.5 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 or longer after the last dose of ocrelizumab, as applicable in the ocrelizumab package leaflet

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1225
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
- Inability to complete a Magnetic resonance imaging (MRI)
- Known presence of other neurological disorders, including but not limited to, the following:
•History of ischemic cerebrovascular disorders or ischemia of the spinal cord
•History or known presence of central nervous system (CNS) or spinal cord tumor
•History or known presence of potential metabolic causes of myelopathy
•History or known presence of infectious causes of myelopathy
•History of genetically inherited progressive CNS degenerative disorder
•Neuromyelitis optica
•History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease
•History of severe, clinically significant brain or spinal cord trauma
Exclusions Related to General Health
- Pregnancy or lactation
- Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug
- 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
- Lack of peripheral venous access
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study
- Congestive heart failure [NYHA] III or IV functional severity).
- Known active bacterial, viral, fungal, mycobacterial infection or other infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening
- History of major opportunistic infections
- History or known presence of recurrent or chronic infection
- History of malignancy, including solid tumors and hematological malignancies
- History of alcohol or drug abuse within 24 weeks prior to baseline
- History or laboratory evidence of coagulation disorders
Exclusions Related to Medications
- Received any prior approved Disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate
- Received a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
- Treatment with any investigational agent within 24 weeks of screening or five half-lives of the investigational drug or treatment with any experimental procedures for MS
- Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
- Previous treatment with B-cell targeted therapies
- Systemic corticosteroid therapy within 4 weeks prior to screening.
- Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies
- Treatment with IV Immunoglobulin within 12 weeks prior to baseline
- Treatment with investigational DMT
- History of recurrent aspiration pneumonia requiring antibiotic therapy
- Treatment with fampridine/dalfamipridine unless on stable dose for = 30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effectiveness of ocrelizumab in early stage of RRMS;Secondary Objective: - To evaluate different clinical measures related to disease progression in early stage of RRMS disease<br>- To evaluate the safety and tolerability of ocrelizumab in early stage of RRMS <br><br>;Primary end point(s): Disease progression;Timepoint(s) of evaluation of this end point: Up to 4 years

Secondary Outcome Measures

Name	Time	Method

Updated 10/8/2021

A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis

Recruitment & Eligibility

Study & Design

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