EUCTR2010-019029-32-DK进行中（未招募）不适用
A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 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
- 2,400
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. Male or female subjects aged 18-65 years
- •3. Subjects with relapsing forms of MS (RRMS; SPMS with superimposed relpases), defined by 2005 revised McDonald criteria.
- •4. Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
- •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. Patients with a manifestation of MS other than relapsing MS.
- •2. Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
- •3. History or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of wether there is evidence of local recurrence or metastase.
- •4. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
- •5. Diagnosis of macular edema during Screening Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic screening visit).
- •6. 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.
- •7. Negative for varicella-zoster virus IgG antibodies at Screening
- •8. Have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 1 month prior to baseline
- •9. Patients who have received total lymphoid irradiation or bone marrow transplantation.
- •10. Patients who expect to be treated with any disease modifying drugs (DMD) during the study (IFN-ß, glatiramer acetate); however no washout is needed for DMDs prior to baseline.
- •For a detailed descrition of all exclusion criteria, please see section 4.2 of the enclosed protocol.
研究者
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