EUCTR2010-019029-32-GB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.
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, 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.
- •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.
- •11. Patients who have been treated with:
- •corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to
- •immunosuppressive medications such as azathioprine or methotrexate within 3 months prior to baseline;
- •immunoglobulins and/or monoclonal antibodies (including natalizumab) within 3
- •months prior to baseline;
- •cladribine, cyclophosphamide or mitoxantrone at any time.
- •12. Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
- •13. Patients with any of the following cardiovascular conditions and/or findings in the
- •screening ECG-recording:
- •history of cardiac arrest;
- •myocardial infarction within the past 6 months prior to enrollment or with current
- •unstable ischemic heart disease;
- •known history of angina pectoris due to coronary spasm or history of Raynaud’s
- •phenomenon;
- •cardiac failure at time of Screening (Class III, according to New York Heart
- •Association Classification) or any severe cardiac disease as determined by the
- •investigator;
- •history or presence of a Mobitz 2 second degree AV block or a third degree AV block
- •or an increased QTc interval >450 ms in males and >470 ms in females corrected
- •using Bazett’s formula;
- •Patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) and III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide,
- •dofetilide).
- •resting pulse rate <45 bpm prior to baseline;
- •bradycardia measured by continuous ambulatory ECG of <40 bpm at any hour (mean) or of <30 bpm at any time (beat to beat)
- •proven history of sick sinus syndrome or sino-atrial heart block;
- •hypertension, not controlled by prescribed medications
- •14. Patients with pulmonary fibrosis
- •15. Patients with any of the following hepatic conditions
- •chronic liver or biliary disease;
- •total bilirubin greater than 2 times the upper limit of the normal range, unless in
- •context of Gilbert’s syndrome
- •conjugated bilirubin great
研究者
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