EUCTR2013-004622-29-ES进行中（未招募）1 期
A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 540
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
- •Inclusion Criteria for MS Patients:
- •- Must have a documented diagnosis of relapsing MS (McDonald 2010 Criteria [Polman 2011]) at study screening.
- •- If the subject is on BRACE at study screening:
- •? He/she must have been on therapy for at least 12 months, and
- •? Experienced ?1 relapse within the last 6 months prior to study screening with ?1 new T1-Gd+ lesion or ?2 new T2 lesions on a brain MRI scan performed ?6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months before study screening.
- •- If the subject is DMT naïve at study screening, he/she must have experienced ?2 relapses in the 12 months prior to study screening. In addition, they must have had ?1 new T1-Gd+ lesion or ?2 new T2 lesions on a brain MRI scan performed ?6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months
- •prior to study screening.
- •- Willing to take natalizumab or fingolimod as the only DMTs for the duration of the study.
- •- Must have an EDSS score from 0 to 5.5 inclusive at study screening.
- •Inclusion Criteria for Healthy Volunteers:
- •- Subjects who are generally healthy as demonstrated by physical examination and by medical history, with no history or evidence of major illnesses, diseases, or disorders.
- •- Subjects of childbearing potential must practice effective contraception and be willing and able to continue contraception for duration of the study.
- •- History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to study screening.
- •- Willing and able to comply with scheduled visits and imaging services.
- •NOTE: Other protocol defined Inclusion criteria may apply
- •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 540
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria for MS Patients:
- •- History of or positive test result at study screening for human immunodeficiency virus (HIV).
- •- History or positive test result at study screening for hepatitis C virus (HCV) antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Subjects with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody [HBsAb] and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and positive HBcAb) are eligible to participate in the study (definitions are based on the United States (US) Centers for Disease Control and Prevention [CDC]?s interpretation of the hepatitis B serology panel).
- •- Prior treatment with natalizumab or fingolimod
- •- Diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary Progressive Multiple Sclerosis [SPMS]
- •- History of or known active malignant disease, including solid tumors and hematologic malignancies (subjects with cutaneous basal and squamous cell carcinoma that has been completely excised and considered cured prior to study screening remain eligible).
- •- History of opportunistic infections (including PML) or any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal condition, or other major disease, as determined by the Investigator.
- •- A clinically significant infectious illness (e.g., pneumonia, septicemia) within the 1 month prior to study screening
- •- History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to study screening
- •- Exposure to intravenous immunoglobulin (IVIg), monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins within one year prior to study screening.
- •- Prior history of immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab) in the last 12 months prior to study screening. Treatment with IV and/or oral corticosteroids (topical corticosteroids are acceptable) within three weeks of baseline DTI-MRI assessment.
- •- An MS relapse that has occurred within the 30 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization.
- •- Current/previous participation in investigational drug studies within 90 days prior to study screening or 5 times the compound?s half-life, whichever is longer.
- •- History or evidence of macular edema on ophthalmologic exam.
- •- History of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure in last 6 months.
- •- Mobitz type II second degree or third degree AV block or sick sinus syndrome, symptomatic bradycardia, recurrent syncope, or severe untreated sleep apnea.
- •- Baseline corrected QTc (Fridericia [QTcF] or Bazett?s [QTcB] formula) interval ?470 ms in females and ?450 ms in males.
- •- Treatment with Class Ia (e.g., procainamide, quinidine, ajmaline, disopyramide) or Class III (amiodarone, bretylium, dofelitide, sotalol, ibulitide, azilimide) anti-arrhythmic drugs.
- •- Concurrent therapy with drugs that slow heart rate (e.g., beta-blockers, heart-rate lowering calcium channel blockers such as diltiazem or verapamil, or digoxin).
研究者
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