NCT01201356已完成3 期
A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,125
- 试验地点
- 1
- 主要终点
- Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death
研究概览
简要总结
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.
详细描述
This study had two parts:
- Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data through approximately 30-Jun-2016 until all end of study (EOS) visits of Part 1 and last follow-up visit through Jan-2017 and
- Part 2, collecting limited safety and tolerability data until approximately 30 Jun 2018, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients who have completed selected ongoing or planned trials with FTY
排除标准
- •Premature permanent discontinuation of a previous fingolimod study.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
- •Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
- •Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
- •Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
- •Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
- •Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:
- •Any of the following cardiovascular conditions that have developed during the previous fingolimod study:
- •Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
- •Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
- •Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
- •History or presence of a third degree AV block
- •Proven history of sick sinus syndrome or sino-atrial heart block
- •Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon
- •Any of the following pulmonary conditions during the previous fingolimod study:
- •Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
- •Active tuberculosis
- •Alcohol abuse, chronic liver disease during the previous fingolimod study.
- •The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.
研究组 & 干预措施
Fingolimod 0.5 mg/day
Experimental
Open-label fingolimod 0.5 mg, taken orally once daily
干预措施: Fingolimod (Drug)
结局指标
主要结局
Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death
时间窗: Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years
Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
次要结局
- Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod(Month 3 to Month 156)
- Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod(Month 12 to Month 156)
- Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod(Month 0 (Core Baseline) to End of Study (an average of Month 156))
- Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume(Month 3 to End of Study (Study Completion Visit))
- Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod(Month 3 to Month 156)
- Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod(Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months))
- Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod(Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months))
- Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume(Month 3 to End of Study (Study Completion Visit))
- Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score(Month 3 to Month 6 Follow-up)
- Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)(Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months))
研究者
研究点 (1)
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