Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 930
- 试验地点
- 1
- 主要终点
- Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany
研究概览
简要总结
The primary objective of this study is to estimate the proportion of DMF use that is prescribed "on-label" versus "off-label". The secondary objectives are: To describe the demographic characteristics and medical history of DMF users; To describe prescription drug history and concomitant medication use of DMF users; To describe the duration of therapy in participants newly initiating DMF treatment; To describe the medical specialties of DMF prescribers.
详细描述
Dimethyl fumarate will not be provided to participants as a part of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New users of dimethyl fumarate will be included in the analysis
排除标准
- •Patients for which data is not available for the 6 months period prior to the index date (baseline observational period)
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Off-Label
Any DMF prescription for MS patients <18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis.
干预措施: dimethyl fumarate (Drug)
On-Label
Prescriptions for patients who are ≥18 years of age and diagnosed with MS
干预措施: dimethyl fumarate (Drug)
结局指标
主要结局
Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany
时间窗: Up to 18 months after market introduction of dimethyl fumarate in Germany
次要结局
- Duration of therapy in participants newly initiating dimethyl fumarate treatment(Up to 18 months after market introduction of dimethyl fumarate in Germany)
- Concomitant medication use of dimethyl fumarate users(Up to 18 months after market introduction of dimethyl fumarate in Germany)
- Demographic characteristics of dimethyl fumarate users(Up to 18 months after market introduction of dimethyl fumarate in Germany)
- Prescription drug history of dimethyl fumarate users(Up to 18 months after market introduction of dimethyl fumarate in Germany)
- Medical history of dimethyl fumarate users(Up to 18 months after market introduction of dimethyl fumarate in Germany)
- Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits.(Up to 18 months after market introduction of dimethyl fumarate in Germany)