EUCTR2019-001341-40-PT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 dimethyl fumarate or fingolimod 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 dimethyl fumarate or fingolimod 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 550
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 6 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, fungal or viral infections (such as hepatitis, HIV, COVID-19), 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 4 weeks 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, daclizumab, cyclophosphamide, teriflunomide etc.)
- •Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator
研究者
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