EUCTR2006-000704-17-PT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
相关药物
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 (Refer to Section 7.5.9 for more details). Females that are either post-menopausal for 12 months prior to Randomization or are surgically sterile (through hysterectomy or bilateral oophorectomy) are not required to use birth control 2. 18 through 55 years of age inclusive
- •3. sign written informed consent prior to participating in the study (Appendix 1).
- •Multiple sclerosis
- •4. diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria (Appendix 3)
- •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) no
- •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
- •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; 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
- •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 daily 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) greater than 2 times the upper limit of the normal range
- •gamma-glutamyl-transferase (GGT) greater than 3 times the upper limit of the normal range
- •14. any of the following abnormal laboratory values:
- •serum creatinine greater than 1.7 mg/dL (150 µmol/L)
- •white blood cell (W
研究者
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