EUCTR2016-002937-31-IT进行中（未招募）1 期
An Open-Label, single-arm study to Evaluate the Effectiveness and Safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis - ENSEMBLE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 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 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
- •- Inability to complete a 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
- •Exclusions Related to Laboratory Findings
- •- Positive serum ß human chorionic gonadotropin measured at screening
- •- Positive
研究者
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