IRCT201112267419N4已完成4 期
Randomized, open labeled, multicenter study evaluating safety Fingolide® in patients with Relapsing- Remitting Multiple Sclerosis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 309
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65 years（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1.Patients with Relapsing- Remitting Multiple Sclerosis (MS) based on McDonald's Criteria (2010)
- •2. Age between 18-50 years old
- •3.Expanded Disability Status Scale (EDSS) 0- 5.5
- •4. Negative pregnancy test at baseline
- •5.Signing consent form
- •6. History of Chicken pox, VZV vaccination or positive antibody.
- •7. At least one documented relapse during one year prior to study while on first line disease modifying therapies.
- •8. No relapse during the last 30 days.
- •Exclusion Criteria :
- •1.Secondry or primary progressive MS
- •2.History of a chronic disease other than MS
- •3. History or presence of malignancy
- •4. Macular edema at onset
- •5. Active bacterial, fungal or viral infection
- •6. Treatment with corticosteorids (IV) during the past 30 days
- •7. Patients who have been previously treated with cyclophosphamide and mitoxantrone
- •8.Patients who have been treated with immunoglubulins or monoclonal antibodies during the past six months
- •9. Patients who have been treated with azothioprine or methtroxate during the past six months
- •10. Patients who have been treated with beta- Interferon or GA during the past 3 months
- •11.Medically Unstable patient according to site physician
- •12. Patient with history of syncope
- •13. History of cardiac arrest, heart failure, recurrent symptomatic bradycardia or ischemic heart disease
- •14. Abnormal Electro Cardio Gram (ECG) (Block, QT interval more than 440 milliseconds on screening ECG
- •15. Hypertension not controlled by prescribed medications
- •16.Patients with severe respiratory disease, Active pulmonary disease, Tuberculosis except successful treatment or prophylactic treatment after positive purified protein derivative (PPD)
- •17. Lost to follow up more than 3 months
排除标准
- 未提供
研究者
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