EUCTR2019-001341-40-IT进行中（未招募）1 期
A single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
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
- •Diagnosis of MS according to the 2017 Revised McDonald criteria
- •Relapsing MS: relapsing forms of MS (RMS)including RMS and secondary progressive MS (SPMS) Lublin et al 2014
- •Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)
- •MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs)
- •Subject transitioning from either fingolimod or dimethyl fumarate which was administered for a period of at least 6 months, as their last DMT before first study drug administration
- •Breakthrough disease activity while the participant was adequately using fingolimod or dimethyl fumarate prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
- •Neurologically stable within one month prior to first study drug administration
- •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 289
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 550
排除标准
- •Subjects with primary progressive MS Polman et al 2011 or SPMS without disease activity Lublin et al 2014
- •Subjects meeting criteria for neuromyelitis optica (Wingerchuk et al 2015)
- •Disease duration of more than 10 years since diagnosis
- •Pregnant or nursing(lactating) women
- •Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 12 months after stopping study medication
- •Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome
- •Subjects with active systemic bacterial, viral or fungal infections, or known to have Acquired Immunodeficiency Syndrome (AIDS)
- •Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML
- •Subjects at risk of developing or having reactivation of syphilis or
- •tuberculosis
- •Subjects at risk of developing or having reactivation of hepatitis: positive results at screening for serological markers for hepatitis A, B, C and E indicating acute or chronic infection
- •Have received any live or live-attenuated vaccines within 2 months prior to first study drug administration
- •Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, etc.)
- •Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the subjects to cooperate or comply with the study procedures
研究者
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