NCT01158183已完成不适用
Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon β-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 226
- 主要终点
- Key Objective: To collect patient reported outcomes and clinical assessments via the same web-based data capture tool in a real world setting in relapse-remitting multiple sclerosis patients
研究概览
简要总结
A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating or resuming Betaseron.
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
- •Provides written informed consent to participate in the study
- •At least 18 but no more than 65 years old
- •Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (CIS)
- •Initiating Betaseron therapy, or resuming Betaseron after not having used it for at least three months
- •Willing and able to provide a valid e-mail address which will be in use for the duration of the study
- •Willing and able to complete study questionnaires via the Internet
- •Has reliable Internet access for the duration of the study
- •Completes the baseline patient questionnaire
排除标准
- •Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0
- •Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire
- •Any use of Betaseron within the three months prior to study entry
- •Inability to read, write, or speak the English language
- •Illness or disease other than multiple sclerosis that the Investigator believes is likely to cause the patient's death or incapacity within twelve months
- •Any severe, uncontrolled illness or condition that the Investigator believes could dominate the patient's quality of life
- •Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with Interferon
- •Current use of any immunosuppressive medication
- •Previous participation in a multiple sclerosis (MS) clinical trial within the three months prior to study entry
- •Previous use of monoclonal antibodies treating MS within the three months prior to study entry
- •Current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations
研究组 & 干预措施
Group 1
No intervention
干预措施: BAY86-5046_Interferon-beta-1b (Drug)
结局指标
主要结局
Key Objective: To collect patient reported outcomes and clinical assessments via the same web-based data capture tool in a real world setting in relapse-remitting multiple sclerosis patients
时间窗: Baseline, 1 to12 month outcome questionnaires
次要结局
未报告次要终点
研究者
相似试验
Unknown
4 期
Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to GilenyaRelapsing Remitting Multiple SclerosisNCT02325440University Hospital Muenster15
终止
2 期
Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)Acute Exacerbation of Remitting Relapsing Multiple SclerosisClinically Isolated SyndromeNCT01039103Galapagos NV15
终止
4 期
Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With DepressionDepressionRelapsing-remitting Multiple SclerosisNCT01436643Novartis Pharmaceuticals54
已完成
2 期
BEYOND Pilot StudyRelapsing-RemittingMultiple SclerosisNCT00893217Bayer71
已完成
不适用
Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple SclerosisMultiple SclerosisNCT00963833Bayer68