EUCTR2008-008719-25-DE进行中（未招募）不适用
A phase II, double-blind, randomized, multi-center, adaptive dose-ranging, placebo-controlled, parallel-group study evaluating safety, tolerability and efficacy on MRI lesion parameters and determining the dose response curve of BAF312 given orally once daily in patients with relapsing-remitting 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
- 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. Patients must give written informed consent before any assessment is performed
- •2. 18 through 55 years of age inclusive
- •3. Male or female
- •4. Females of childbearing potential:
- •must have a negative pregnancy test at Baseline prior to entry into the double-blind treatment phase
- •must simultaneously use two forms of effective contraception (either partner) during the treatment and for one
- •months or one menstrual cycle, whichever is longer after discontinuation of the study drug
- •if either post-menopausal for 12 months prior to randomization or surgically sterile (through hysterectomy
- •or bilateral oophorectomy, if documented), are not required to use birth control (refer to Section 8.3 for more
- •5. Diagnosis of MS as defined by revised McDonald criteria (see Appendix 4)
- •6. A relapsing-remitting course of disease with
- •at least 1 documented relapse during the previous year, or
- •2 documented relapses during the previous 2 years, or
- •a positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a
- •second scan may be obtained 1 month later)
- •7. An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization
- •8. Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to
- •randomization
- •9. Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for
- •whatever reason, after having been informed about their respective benefits and possible adverse events by the
- •investigator.
- •10. Is willing to refrain from submersion in water while wearing the MCT adherent device during dose titration
- •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
- •1. Another type of MS than RRMS
- •2. History of chronic disease of the immune system other than MS, or a known immunodeficiency syndrome
- •3. Malignancy (except for successfully-treated basal or squamous cell carcinoma of skin)
- •4. Known, or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes a patient should be further evaluated)
- •5. Macular edema during pre-randomization
- •6. Active systemic bacterial, viral or fungal infections, or AIDS, hepatitis B, hepatitis C infection defined as a positive HIV AB, hepatitis B surface AG or hepatitis C AB tests
- •7. Negative for varicella-zoster virus IgG AB at screening
- •8. Live or live attenuated vaccination within 2 m
- •9. Total lymphoid irradiation or bone marrow transplantation
- •10. Have been treated with:
- •ACTH or oral or injected corticosteroids within 1 m
- •IFN-ß or glatiramer acetate within 3 m
- •immunosuppressive medications such as azathioprine or methotrexate within
- •immunoglobulins and/or monoclonal ABs (including natalizumab) within 6 m (this rule does not apply for alemtuzumab, rituximab)
- •alemtuzumab, rituximab, cladribine, cyclophosphamide, mitoxantrone, or other immunosuppressive treatments with effects potentially lasting over 6 m, at any time
- •11. Any medically unstable condition, as assessed by the primary treating physician
- •12. Any of the following CV conditions
- •history or presence of stable or unstable IHD, MI, myocarditis or cardiomyopathy
- •history of Raynaud’s disease
- •cardiac failure (NYHA class II - IV) at screening and/or at baseline, or any severe cardiac disease as determined by the investigator
- •history of cardiac arrest
- •history of symptomatic bradycardia
- •resting pulse rate < 55 bpm
- •history or presence of a clinically relevant impairment of cardiac conduction including sick sinus syndrome, sino-atrial block
- •clinically significant AVB, bundle branch block or an increased QTc interval > 440 msec on screening ECG
- •history or presence of symptomatic arrhythmia or arrhythmia requiring treatment or being otherwise of clinical significance
- •arterial hypertension, uncontrolled by medication
- •treatment with medication that impairs cardiac conduction
- •history of syncopes of suspected cardiac origin
- •history of catheter ablation
- •13. Any of the following pulmonary conditions:
- •severe respiratory disease or pulmonary fibrosis
- •tuberculosis, except for history of successfully treated TB or history of prophylactic treatment after positive PPD skin reaction
- •abnormal chest High Resolution Computer Tomography (HRCT), chest X-Ray or chest MRI suggestive of active pulmonary disease
- •abnormal Pulmonary Function Tests: forced expiratory volume in 1 second (FEV1) or forced vital capacity
- •(FVC) values lower than 70% of predicted value
- •patients receiving chronic (daily) therapies for asthma
- •14. Any of the following hepatic conditions:
- •chronic liver or biliary disease
- •total bilirubin >ULN unless in context of Gilbert’s syndrome
- •conjugated bilirubin >ULN
- •alkaline phosphatase (AP) >1.5 x ULN
- •AST or SGOT, ALT or SGPT >2 x ULN
- •GGT >3 x ULN
- •15. Any of the following abnormal laboratory values:
- •potassium >ULN
- •serum creatinine > 1.7 mg/dL (150 µmol/L)
- •white blood cell count < 3,500/mm3 (< 3.5 x 109/L)
- •lymphocyte count < 800/mm3 (< 0.8 x 109/L)
- •16. Any of the following neurological/psychiatric disorders:
- 另有 2 项未显示
研究者
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