Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 468
- 主要终点
- Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time
研究概览
简要总结
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).
Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare Pharmaceuticals Inc..
Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS or by completing 24 months
排除标准
- •No participation in the initial BENEFIT study
研究组 & 干预措施
Initial IFNB-1b (Interferon beta-1b)
Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Initial Placebo
Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time
时间窗: up to 60 months after start of treatment
CDMS could be reached due to a qualifying relapse or sustained progression of 1.5 points on the expanded disability status scale (EDSS) as compared to the lowest EDSS obtained during screening or Day 1. The validity of CDMS diagnoses was confirmed by a central committee. The EDSS scale quantifies disability in MS in 8 functional systems, values vary between 0="normal neurological examination" and 10="death due to MS" measured in half-points on an ordinal scale. Time to CDMS = date of CDMS - date of Day 1 + 1 or time to CDMS = date of last clinical visit - date of Day 1 + 1 (right-censored)
Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time
时间窗: up to 60 months after start of treatment
EDSS progression was defined as an increase in the expanded disability status scale (EDSS) of 1.0 point compared to the lowest EDSS score obtained during the screening or baseline visit, if this score was \<= 5.5. A confirmed EDSS progression status was defined as an EDSS progression observed at two consecutive scheduled visits at least 140 days apart from each other. The EDSS scale is a method of quantifying disability in multiple sclerosis in eight functional systems and values vary between 0="normal neurological examination" and 10="death due to MS" measured in half-points on a scale.
Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60
时间窗: 60 months after start of treatment
As an index of health related quality of life in people diagnosed with MS, the FAMS Trial Outcome Index covers overall physical health (sum of sub-scale scores Mobility, Symptoms, Thinking/Fatigue, Additional Concerns) with a score range from 0 to 148. A higher score reflects a higher overall physical health as reported by patients.
次要结局
- Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria(up to 60 months after start of treatment)
- Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses(up to 60 months after start of treatment)
- Relapse-based Efficacy Domain (Supportive): Annualized Relapse Rate(up to 60 months after start of treatment)
- MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60(60 months after start of treatment)
- MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60(up to 60 months after start of treatment)
- Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60(60 months after start of treatment)
- MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60(60 months after start of treatment)
- MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60(60 months after start of treatment)