jRCT2021220014已完成不适用
SAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 74age old under（—）
- 性别
- All
入选标准
- •Age 18 to 74 years, inclusive, at the time of informed consent
- •Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
- •For women of childbearing potential: agreement to either remain abstinent (refrain from heterosexual intercourse) or to use reliable means of contraception (physical barrier [patient or partner] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug
- •Cohort 1 (treatment-naive NMOSD patients)
- •Confirmation of NMOSD diagnosis with AQP4+ antibodies
- •Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last year prior to screening
- •Naive to maintenance therapy (disease-modifying therapy [DMT] or immunosuppressive therapy [IST])
- •Cohort 2 (NMOSD patients with inadequate response to RTX [or its biosimilar])
- •Confirmation of NMOSD diagnosis and AQP4+ antibodies in the disease history of the patient
- •Have a length of disease duration from first symptom of =5 years
- •History of ongoing treatment with RTX (or its biosimilar) (at least 2 infusions) for NMOSD with a maximum duration of 6 months since last administration prior to enrolment in the study
- •Ongoing disease activity after last RTX (or its biosimilar) infusion i.e., relapse and/or any new inflammatory event, confirmed by magnetic resonance imaging (MRI) or ophthalmological assessment
- •Count, volume and regional distribution of T2-weighted fluid-attenuated inversion-recovery (FLAIR) hyperintense lesions
- •Including new and enlarging lesions of the cerebrum, optic nerves, optic chiasm, area postrema, brainstem and cerebellum; Fazekas scoring
- •Global and regional brain volume loss including basal ganglia, cerebellum and upper cervical spinal cord.
- •New and persisting short T1 inversion recovery (STIR)/Proton Density (PD) hyperintense lesions and T1-weighted contrast enhancement
- •Quantitative T1 mapping
- •Quantitative diffusion/diffusion tensor imaging (DTI)
- •Change in the retinal nerve fiber layer (RNFL) thickness
- •Change in the ganglion cell plus inner plexiform (GCIP) layer thickness
- •Incidence and severity of adverse events (AEs), serious AEs (SAEs) and AEs of special interest (AESIs)
排除标准
- •Exclusion criteria for both the cohorts
- •Inability to complete an MRI
- •Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
- •Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
- •Evidence of other demyelinating disease, including multiple sclerosis or progressive multifocal leukoencephalopathy
- •Evidence of serious uncontrolled concomitant diseases that may preclude patient participation
- •Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection or other infection (excluding fungal infections of nail beds or caries dentium) at baseline
- •Infection requiring hospitalization or treatment with intravenous (IV) anti-infective agents within 4 weeks prior to baseline visit
- •Evidence of chronic active hepatitis B
- •Evidence of active tuberculosis (TB)
- •History or laboratory evidence of coagulation disorders
- •Receipt of a live or live-attenuated vaccine within 6 weeks prior to baseline
- •Presence or history of malignancy
- •History of drug or alcohol abuse within 1 year prior to baseline History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation
- •History of severe allergic reaction to a biologic agent
- •Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening
- •Treatment with any investigational agent within 6 months prior to baseline or 5 drug elimination half-lives of the investigational agent (whichever is longer)
- •Cohort 1 (treatment-naive NMOSD patients)
- •Any previous treatment with IL-6 inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, stem-cell therapy, or bone marrow transplantation
- •Any previous treatment with eculizumab, belimumab, natalizumab, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate, siponimod, or ozanimod
- •Any previous treatment with anti-CD4, cladribine or mitoxantrone
- •Any previous treatment with B-cell depleting agents
- •Any previous treatment with immunosuppressants
- •Cohort 2 (NMOSD patients with inadequate response to RTX)
- •Discontinued RTX (or biosimilar) treatment due to any other reason than inadequate response to treatment
结局指标
主要结局
Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
时间窗: over the course of the study
The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments. Higher results represent higher levels of disability.
次要结局
- Count, volume and regional distribution of T2-weighted fluid-attenuated inversion-recovery (FLAIR) hyperintense lesions
研究者
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