Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis (MS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 26
- 主要终点
- Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
研究概览
简要总结
This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).
详细描述
This was a multicenter follow-up study of patients originally enrolled in the Phase 2 D2201 study. Patients did not receive any protocol specified treatment. The original D2201 study sites who agreed to participate in this study were required to locate their patients who were randomized in Study D2201 and asked them to return for a 10-year assessment, regardless of their current treatment status. Locating the patient may have required the use of search and advertising strategies to find those patients currently lost to follow-up, in accordance with local privacy legislation. Patients currently being followed within Study FTY720D2399 (NCT01201356) were asked to participate in Study FTY720D2201E2 and if patients gave consent, were enrolled concurrently in both studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed.
- •Randomized in study FTY720D2201 and received at least one dose of study drug.
排除标准
- 未提供
研究组 & 干预措施
Phase 2 CFTY720D2201 (NCT02307838) participants
CFTY720D2201E2 participants did not receive any protocol specified treatment. The original D2201 study sites, who agreed to participate in this study, were required to locate their participants who were randomized in D2201 and asked them to return for a 10 year assessment, regardless of current treatment status.
干预措施: Assessments arm (Other)
结局指标
主要结局
Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
时间窗: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.
次要结局
- Percentage Brain Volume Change (PBVC)(baseline from core study (CFTY720D2201 (NCT00333138)), 10 years)
- Number of Participants With Disability Progression(10 Years)
- Percentage of Participants With First Use of a Wheelchair(10 years)
- Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score(baseline from core study (CFTY720D2201 (NCT00333138)), 10 years)
- Number of Participants Classified as Secondary Progressive MS (SPMS)(10 years)
- Percentage of Participants With First Use of an Ambulatory Device(10 years)
- Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score(baseline from core study (CFTY720D2201 (NCT00333138)), 10 years)
- Number of Participants With EDSS <4 or <6(10 years)
- Number of Participants Not Using a Wheelchair or Being Bedridden(10 years)
- Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score(baseline from core study (CFTY720D2201 (NCT00333138)), 10 years)
- Change From Baseline in Total Volume of T2 Lesion(baseline from core study (CFTY720D2201 (NCT00333138)), 10 years)
- Third Ventricle Diameter(10 years)
- Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters(10 years)
- Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)(baseline from core study, CFTY720D2201 (NCT00333138), 10 years)
- Total Volume in T2 Lesion(10 years)
- Change From Baseline in Third Ventricle Diameter(baseline from core study (CFTY720D2201 (NCT00333138)), 10 years)