EUCTR2019-001341-40-NO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
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
- •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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