ISRCTN11671729终止未知
A Phase 4, 5-year, multicenter, prospective, observational, single-cohort study to document utilization, effectiveness and safety of daclizumab in subjects with relapsing forms of MS in clinical practice in Germany
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- Biogen GmbH
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Ability to understand the purpose of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations
- •2. Start of daclizumab therapy in accordance with local prescribing information; the decision for the daclizumab therapy must be made before study inclusion; patients can be enrolled until before administration of fourth daclizumab dose - provided baseline data are available
- •3. Aged at least 18 years at time of enrolment; no upper age limit
排除标准
- •1. Missing ability or willingness to give informed consent after information about the study
- •2. Missing eligibility for participation from physician's point of view
- •3. Contraindication to treatment with daclizumab or diseases which are contraindicated according to the local prescribing information
- •4. Concomitant therapy with another disease-modifying MS-therapy
- •5. Current or planned participation in a clinical interventional study
研究者
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