NCT06885957招募中不适用
A Registry Study on Monoclonal Antibody-Based Therapies for Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorders
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to first relapse
研究概览
简要总结
The primary objective of this registry study is to evaluate the therapeutic efficacy and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders within the Chinese population under real-world clinical conditions. Secondary objectives include quantitative assessment of longitudinal neuroimaging biomarker variations and immunological profile alterations in longitudinal biological specimens pre- and post-therapeutic intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must demonstrate capacity to comprehend the study's objectives and associated risks, provide written informed consent, and authorize utilization of confidential health information in compliance with national and regional data protection regulations.
- •Enrollment is permitted regardless of biological sex, with age ≥18 and ≤65 years (inclusive) at the time of informed consent provision.
- •All females of childbearing potential and biologically male participants must employ contraceptive measures meeting clinical trial standards throughout the study duration and for at least 30 days following the final administration of investigational therapy. Additionally, participants must abstain from gamete donation during the study period and for ≥30 days post-treatment cessation.
- •Confirmed diagnosis of aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive neuromyelitis optica spectrum disorders (NMOSD) per the 2015 International Consensus Diagnostic Criteria, with serological or cerebrospinal fluid verification of AQP4-IgG positivity for inclusion in the AQP4-NMOSD cohort. Participants must have provided documented consent for therapeutic intervention with one monoclonal antibody-based biologics.
- •Neurological examination demonstrating clinical stability within 30 days preceding baseline (Visit 1).
排除标准
- •Medical History and Current Health Status
- •Clinically significant medical history of cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, renal, pulmonary, neurological, dermatologic, psychiatric, or other major systemic conditions that, in the investigator's judgment, would preclude safe trial participation.
- •Prior cerebrovascular events resulting in a baseline modified Rankin Scale (mRS) score >
- •Hypersensitivity to the investigational therapeutic agent(s) or their excipients.
- •Infection Risk
- •Documented history or positive screening test for human immunodeficiency virus (HIV).
- •Active hepatitis C virus (HCV) infection, defined as detectable HCV RNA with concomitant anti-HCV antibody positivity. Subjects with anti-HCV antibody positivity and undetectable HCV RNA remain eligible.
- •Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity and/or total hepatitis B core antibody (anti-HBc) positivity. Subjects with prior natural infection (HBsAg-negative, anti-HBc-positive, and anti-HBs-positive) or vaccination-induced immunity (HBsAg-negative, anti-HBc-negative, and anti-HBs-positive) are eligible.
- •Chronic, recurrent, or severe infections (e.g., pneumonitis, sepsis) within 90 days prior to baseline (Visit 1).
- •History of active tuberculosis (TB) or latent TB infection, defined by positive interferon-gamma release assay (IGRA) results or two consecutive tuberculin skin tests.
- •Active bacterial, fungal, or viral infections (including upper respiratory tract infections) within 28 days prior to baseline. Subjects with localized fungal infections (e.g., candidiasis, dermatophytosis) may undergo re-screening post-treatment.
- •Contraindications to rescue therapies, including rituximab, intravenous immunoglobulin (IVIG), high-dose corticosteroids, or cyclophosphamide.
- •Prior exposure to total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination, total body irradiation, or hematopoietic stem cell transplantation at any time.
- •Additional Exclusion Criteria
- •Clinically significant suicidal ideation or behavior within the past 12 months, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- •Unwillingness or inability to comply with protocol-mandated procedures.
- •Severe auditory/visual impairment, language barriers, claustrophobia, or other conditions precluding neuropsychological assessments or MRI completion.
- •Any other condition deemed by the investigator or sponsor to compromise subject eligibility or study integrity.
研究组 & 干预措施
Inebilizumab treatment
AQP4-IgG positive NMOSD Patient who received Inebilizumab
干预措施: Mab Therapy (Drug)
Satralizumab treatment
AQP4-IgG positive NMOSD Patient who received Satralizumab
干预措施: Mab Therapy (Drug)
Eculizumab treatment
AQP4-IgG positive NMOSD Patient who received Eculizumab
干预措施: Mab Therapy (Drug)
Ofatumumab treatment
AQP4-IgG positive NMOSD Patient who received Ofatumumab
干预措施: Mab Therapy (Drug)
Rituximab treatment
AQP4-IgG positive NMOSD Patient who received Rituximab
干预措施: Mab Therapy (Drug)
结局指标
主要结局
Time to first relapse
时间窗: Up to 96 weeks
Median time to relapse
时间窗: Up to 96 weeks
Annualized relapse rate
时间窗: Up to 96 weeks
EDSS score
时间窗: Up to 96 weeks
次要结局
- Incidence of radiologically identified new gadolinium-enhancing lesions and/or new or enlarging T2-weighted lesions(Up to 96 weeks)
- AQP4-IgG titer in serum and cerebral spinal fluid(Up to 96 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
CP-675,206 In Patients With Advanced MelanomaMalignant MelanomaNCT00086489AstraZeneca118
Unknown
不适用
Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal CancerMetastatic Colon CancerNCT02254941Grupo Espanol Multidisciplinario del Cancer Digestivo1,104
已完成
1 期
Monoclonal Antibody Treatment for Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT00046774National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)23
已完成
1 期
A Study to Assess the Safety, Pharmacokinetics and Effectiveness of AGS-16C3F Monotherapy in Subjects With Renal Cell Carcinoma (RCC) of Clear Cell or Papillary HistologyCarcinoma, Renal CellRenal Cell Carcinoma of Papillary HistologyRenal Cell Carcinoma With Clear Cell HistologyRenal Cell Carcinoma With Non-Clear Cell HistologyNCT01672775Agensys, Inc.34
招募中
1 期
Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and AboveVaccine-Preventable DiseasesHerpes ZosterNCT06137755CHA Vaccine Institute Co., Ltd.32