NCT01076595已完成不适用
Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program
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
- 73
- 主要终点
- The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)
研究概览
简要总结
The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >/= 18 years old
- •Outpatient with a confirmed diagnosis of Recurrent-Remittent multiple sclerosis or patients at high risk of developing multiple sclerosis after a first demyelinating clinical event
- •Patient who initiated Betaferon as described by SmPC less than 2 months ago. The decision of physician is clearly separated from the decision to include the patient in the study
- •Treatment naïve patients before the initiation of Betaferon
- •OR Patients having interrupted Betaferon for more than 6 months before to start again
- •OR Patients receiving a disease modifying drug (DMD) other than Betaferon
- •Patient with EDSS score < 4
- •Patients approved and signed an inform consent and approved the collect of their data
排除标准
- •Contraindications and warning of the respective Summary of Product Characteristics
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
The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)
时间窗: 24 months
次要结局
- Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)(6 months, 12 months, 24 months)
- Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)(6 months, 12 months)
- Rate of patients with prematurely study discontinuation(0-6 months, 6-12 months, 12-18 months, 18-24 months)
- Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections)(24 months)
- Tolerability of Betaferon injections (rate and number of injections)(24 months)
- Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])(24 months)
- Fatigue (mean total score of FSS [Fatigue Severity scale])(24 months)
- Progression of clinical Condition( annual rate of Relapses)(24 months)
- Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study(24 months)
- Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24(24 months)
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