An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis
- Conditions
- msmultiple sclerosis10012303
- Registration Number
- NL-OMON50626
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
- 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
(Polman et al. 2011)
- 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 ocrelizimab, as applicable in the ocrelizumab package
leaflet
- 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 attanuated 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. Wh
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary goal of this study is to determine the efficacy of ocrelizumab by<br /><br>evaluating clinical measures related to disease progression over 4 years in<br /><br>patients in the early stage of their RRMS disease.</p><br>
- Secondary Outcome Measures
Name Time Method