EUCTR2010-022066-28-DE进行中（未招募）1 期
A 6-month multicenter, single-arm, open-label study to investigate changes in biomarkers after initiation of treatment with 0.5 mg fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosis
ovartis Pharma GmbH0 个研究点目标入组 445 人开始时间: 2010年9月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 445
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. Written informed consent from patients capable of giving or withholding full informed
- •consent must be obtained before any assessment is performed.
- •2. Male or female subjects aged 18-65 years.
- •3.Subjects with relapsing remitting forms of MS defined by 2010 revised McDonald
- •criteria (see Appendix 4).
- •4.Patients with high disease activity despite treatment with a disease modifying therapy
- •(= 1 relapse in the previous year, = 9 hyperintense T2 lesions or =1 Gd-enhancing
- •lesion or non-responding” which could be defined as unchanged or increased relapse
- •rate or ongoing severe relapses compared to previous year)
- •or patients with rapidly evolving severe RRMS (e.g. = 2 relapses with disease
- •progression in one year and = 1 Gd-enhancing lesion or with a significant increase in
- •T2 lesions compared to a recent MRI).
- •5.Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 (see Appendix
- •6.Sufficient ability to read, write, communicate and understand
- •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 445
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with a manifestation of MS other than relapsing remitting 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 cell carcinoma of the skin and carcinoma in situ of the cervix) in the last 5 years
- •4. Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 7%.
- •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 (i.e. IFN-ß, glatiramer acetate); however no washout is needed for DMDs prior to baseline.
- •11. Patients who have been treated with:
- •systemically applied corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to baseline;
- •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 at any time
- •Cyclophosphamide and mitoxantrone within 6 months prior to start of fingolimod
- •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:
- •Patients receiving antiarrythmics class Ia (e.g. quinidine, disopyramide, chinidin,
- •ajmaline, procainamide) or class III (e.g. amiodarone, bretylium, sotalol, ibutilide,
- •azimilide, dofetilide) or beta blockers
- •Patients receiving heart rate lowering calcium channel blockers (e.g. verapamil,
- •diltiazem or ivabradine) or other substances which may decrease heart rate (e.g.
- •digoxin, anticholinesteratic agents or pilocarpine).
- •Significant QT prolongation (QTc>470 msec (female) or >450 msec (males))
- •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 of second degree AV block, sick-sinus syndrome or sinoatrial block.
- •History of symptomatic bradycardia or recurrent syncope, known ischaemic heart
- •disease, cerebrovascular disease, history of myocardial infarction, congestive heart
- •failure, history of cardiac arrest, uncontrolled hypertension, or severe sleep apnea
- •resting pulse rate <45 bpm;
- •14. Patients with any of the following pulmonary conditions:
- •pulmonary fibrosis
- •active tuberculosis
- •15. Patients with severe hepatic dysfunction (Child-Pugh-Class C)
- •16. Patients with any of the abnormal laboratory values:
- •white blood cell (WBC) count <3,500/mm3 or lymphocyte count <800/mm3
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