NCT00544037已完成不适用
Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 283
- 主要终点
- To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study
研究概览
简要总结
To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.
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
- 23 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients randomized and treated at least once in study 304747
排除标准
- •Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
研究组 & 干预措施
Group 1
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study
时间窗: End of Study
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up StudyMultiple SclerosisNCT00185211Bayer468
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1 期
Extension to the MAGNIFY MS trial on Mavenclad®EUCTR2020-003995-42-PLMerck Healthcare KGaA256
进行中（未招募）
1 期
Extension to the MAGNIFY MS trial on Mavenclad®Highly-active relapsing multiple sclerosisMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-003995-42-ITMERCK KGAA261