EUCTR2007-004122-24-HU进行中（未招募）不适用
An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients should complete the 24 month core study
- •2. Written informed consent provided prior to participation in extension study
- •3. Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Premature discontinuation of the study drug during the core study FTY720D2301 due to:
- •a. An adverse event or serious adverse event or laboratory abnormality, except pregnancy
- •b. Conditions leading to permanent study drug discontinuation such as macular edema, elevated liver enzymes five times ULN (upper limit of normal), pulmonary function tests below 60% of baseline values. The full description of these exclusion criteria and monitoring guidelines is outlined in Appendix 4: Guidance on Safety Monitoring
- •2. Chronic disease of the immune system other than MS which may require immunosuppressive treatment
- •3. History or presence of malignancy
- •4. Known diagnosis of diabetes mellitus or a blood glucose obtained suspicious for diabetes (= 126 mg/dl or = 7 mmol/L if fasting; = 200 mg/dl or = 11.1 mmol/L if random)
- •5. Macular edema during the core study
- •6. 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
- •7. Previous treatment with cladribine, cyclophosphamide or mitoxantrone
- •8. Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months
- •9. Any medically unstable condition, that may interfere with the patient’s ability to cooperate and comply with the study procedures, as assessed by the treating physician
- •10. Any of the following cardiovascular conditions:
- •a. myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
- •b. cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
- •c. arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide)
- •d. history or presence of a third degree AV block
- •e. proven history of sick sinus syndrome or sino-atrial heart block
- •f. known history of angina pectoris due to coronary spasm or Raynaud’s phenomenon
- •11. Any of the following pulmonary conditions:
- •a. Severe respiratory disease or pulmonary fibrosis diagnosed [during the core study]
- •b. History of tuberculosis
- •c. Abnormal chest x-ray or high resolution computer tomography (HRCT) [at selected sites] suggestive of active pulmonary disease in the core study
- •12. Known history of alcohol abuse, chronic liver disease
- •13. Current participation in any clinical research study evaluating another investigational drug or therapy
- •14. Female patients that are nursing (lactating)
研究者
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