EUCTR2006-000704-17-GB进行中（未招募）不适用
A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,275
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. male or female;
- •females of childbearing potential must:
- •- have negative pregnancy tests prior to entry into the Double-Blind Treatment Phase
- •- use simultaneously two forms of effective contraception (either partner) during the treatment and for 3 months after discontinuation of the study medication
- •females that are either post-menopausal for 12 months prior to Randomisation or are sugically sterile (through hysterectomy or bilateral oophorectomy) are not required to use birth control
- •2. 18 through 55 years of age inclusive
- •3. signed written informed consent prior to participating in the study.
- •Multiple sclerosis
- •4. diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria
- •5. a relapsing-remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years; prior to randomization
- •6. an Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive
- •7. neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following exclusion criteria during the Pre-Randomization Phase will not be eligible for enrollment in the study:
- •1. a manifestation of MS other than RRMS
- •2. a history of chronic disease of the immune system other than MS or a known
- •immunodeficiency syndrome
- •3. a history of epileptic seizures within 3 months of randomization
- •4. a history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)
- •5. a known or ‘new’ diagnosis of diabetes mellitus
- •6. a diagnosis of macular edema during Pre-randomization 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).
- •7. active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
- •8. have received total lymphoid irradiation or bone marrow transplantation
- •9. have been treated with:
- •systemic corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to randomization
- •immunosuppressive medications such as azathioprine or methotrexate within 6 months prior to randomization
- •immunoglobulins and/or monoclonal antibodies (including natalizumab) within 6 months prior to randomization
- •cladribine, cyclophosphamide or mitoxantrone at any time
- •10. any medically unstable condition, as assessed by the primary treating physician
- •11. any of the following cardiovascular conditions:
- •myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease
- •history of angina pectoris due to coronary spasm or history of Raynaud’s phenomenon
- •cardiac failure at time of Screening (Class III, according to NYHA Classification; or any severe cardiac disease as determined by the investigator
- •history of cardiac arrest
- •history of symptomatic bradycardia
- •resting pulse rate <55 bpm prior to randomization
- •history of sick sinus syndrome or sino-atrial heart block
- •history or presence of a second degree AV block or a third degree AV block or an increased QTc interval >440 ms on Screening ECG
- •arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide)
- •history of a positive tilt test from workup for vasovagal syncope
- •hypertension, uncontrolled by medication
- •12. any of the following pulmonary conditions:
- •severe respiratory disease or pulmonary fibrosis
- •tuberculosis, except for history of successfully treated tuberculosis or history of prophylactic treatment after positive PPD skin reaction
- •abnormal chest High Resolution Computer Tomography (HRCT) [or chest x-ray in case HRCT is not permitted by local regulations] suggestive of active pulmonary
- •abnormal Pulmonary Function Tests: FEV1;, FVC values lower than 70% of predicted value, DLCO values lower than 60% of predicted value
- •patients receiving chronic therapies for asthma
- •13. any of the following hepatic conditions:
- •known history of alcohol abuse, chronic liver or biliary disease
- •total bilirubin greater than the upper limit of the normal range, unless in context of Gilbert's syndrome
- •conjugated bilirubin greater than the upper limit of the normal range
- •alkaline phosphatase (AP) greater than 1.5 times the upper limit of the normal range
- •AST (SGOT), ALT (SGPT) g
研究者
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