EUCTR2010-020515-37-DK进行中（未招募）不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Patients who have completed designated ongoing or planned trials with fingolimod.
- •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
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •1. Premature permanent discontinuation of a previous fingolimod study.
- •2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml).
- •3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods, at least 1 of which must be a primary form.
- •4. Chronic disease of the immune system other than MS which may require immunosuppressive treatment.
- •5. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
- •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 during the previous fingolimod study.
- •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 that have developed during the previous fingolimod study.
- •For a detailed descrition of all exclusion criteria, please see section 4.2 of the enclosed protocol.
研究者
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