Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 4
- 主要终点
- Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.
研究概览
简要总结
Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and Male patients aged 18 and more;
- •Confirmed diagnosis of RRMS according to the MacDonald or Poser criteria;
- •First indication for Betaferon treatment (as described in Summary of Product Characteristics (SmPC));
- •No relapse of multiple sclerosis (MS) in the last two months before the inclusion;
- •Walking patients having an Expanded Disability Status Scale (EDSS) score between > 1 and </= 4 at the inclusion visit;
- •Female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;
- •Patient can follow all the study and comply with all procedures of the trial protocol
- •Laboratory evaluations (i.e. evaluation of hepatic enzymes gammaGT, full blood count and differential white blood cell [WBC]) must be available and the results must be normal;
- •Written informed consent.
排除标准
- •Any contraindication to Betaferon as described in the SmPC of the product;
- •Patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
- •Patient previously included in this study;
- •Patient previously treated within the past 3 months with Rebif, Avonex or Copaxone;
- •Patient previously treated within the past 12 months with Betaferon;
- •Participation in any clinical trial within the past 30 days involving the investigational drug intake.
研究组 & 干预措施
Interferon beta-1b, FRP within 15 days after randomization
Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization
干预措施: Interferon beta-1b, FRP within 15 days after randomization (Drug)
Interferon beta-1b, FRP about 6 weeks after randomization
Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization
干预措施: Interferon beta-1b, FRP about 6 weeks after randomization (Drug)
结局指标
主要结局
Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.
时间窗: Up to 6 minutes
Time of Discomfort Appearance
时间窗: Up to 6 minutes
Distance of Discomfort Appearance
时间窗: Up to 6 minutes
Rhythm Change During 6 Minutes Walking Test
时间窗: Up to 6 minutes
次要结局
- Covered Distance Gain Between MR2 Visit and MR3 Visit(At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit))
- Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit(At baseline and 12 weeks after MR1 visit)
- Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit(At baseline and 12 weeks after MR1 visit)
- Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits(At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit))
- Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)(From baseline to 12 weeks after MR1 visit)
- Quality of Life Assessed by Use of Self-questionnaire (SEP-59)(From baseline to 12 weeks after MR1 visit)