A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsing remitting Multiple Sclerosis
- •Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
排除标准
- •Patients with MS other than relapsing remitting MS
- •Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
- •Patients who have been treated with:
- •systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
- •immunosuppressive medications within 3 months prior to baseline;
- •monoclonal antibodies within 3 months prior to baseline;
- •cladribine, mitoxantrone or alemtuzumab at any time.
- •Uncontrolled diabetes mellitus at screening
- •Diagnosis of macular edema during Screening Phase
- •Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
- •Patients who have received total lymphoid irradiation or bone marrow transplantation.
- •Patients with certain cardiovascular conditions and/or findings in the screening ECG
- •Patients with certain liver conditions
- •Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Fingolimod
Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
干预措施: Fingolimod (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: 28 weeks
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
次要结局
- Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.(4 months)