NL-OMON50626已完成3 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 / MA30143
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •(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
排除标准
- •- 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.
- 另有 7 项未显示
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisRelapsing remitting multiple sclerosis (RRMS)MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-002937-31-GBF. Hoffmann-La Roche Ltd1,225
进行中（未招募）
1 期
A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisRelapsing remitting multiple sclerosis (RRMS)MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-002937-31-SKF. Hoffmann-La Roche Ltd1,225
进行中（未招募）
1 期
A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisEUCTR2016-002937-31-BGF. Hoffmann-La Roche Ltd1,225
进行中（未招募）
1 期
A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisEUCTR2016-002937-31-FRF. Hoffmann-La Roche Ltd600
进行中（未招募）
1 期
A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisEUCTR2016-002937-31-PLF. Hoffmann-La Roche Ltd1,225