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 96-week treatment period
Exclusio

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>;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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