EUCTR2012-000411-91-DE进行中（未招募）1 期
Monitoring natural killer cells in multiple sclerosis patients treated with fingolimod: a monocentric, prospective, one year, baseline-to-treatment, open-label, single group pilot trial - NKZellen-Version1.0
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Definite diagnosis of RRMS according to the 2010 revised McDonald criteria (Polman et al., 2011)
- •18 to 65 years old
- •Indication for on-label treatment with fingolimod (Gilenya®) ac-cording to the current approval
- •EDSS score = 6,0
- •Neurological stable with no evidence of relapse or corticosteroid treatment within 30 days prior to screening
- •Ability to provide written informed consent
- •Highly effective contraception (Pearl Index < 1), reliable absti-nence from any heterosexual relationships, or sterilization of the only partner in women of childbearing potential
- •Negative pregnancy test (HCG rapid test in the urine) at screen-ing and baseline in women of childbearing potential
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with MS manifestations other than RRMS
- •Patients with known contraindications to Gilenya® according to the current Fachinformation”, in particular
- •Immunodeficiency syndrome
- •Increased risk of opportunistic infections
- •Severe active or chronic active infections (hepatitis, tubercu-losis)
- •History or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin).Severe liver dysfunction (Child Pugh C)
- •Hypersensitivity against active or any other compound of study medication
- •2nd degree Mobitz Type II or higher degree AV block, Sick-sinus syndrome, or Sinu-atrial heart block, Significant QT pro-longation (QTc>470 msec (female) or >450 msec (males))
- •History of symptomatic bradycardia or recurrent syncope, known ischaemic heart disease, cerebrovascular disease, history of my-ocardial infarction, hypokalaemia, congestive heart failure, history of cardiac arrest, uncontrolled hypertension, or severe sleep ap-neaPatients with clinically significant liver, kidney or bone marrow dysfunction, defined by the following laboratory values at the time of screening:
- •HB <8.5 g / dl
- •WBC <2.5 / nl
- •platelets <100/nl
- •creatinine clearance by Cockroft-Gault formula: Cl <110ml/min (men) and Cl <95ml/min (women), from age of 30 limit drops 10ml/min per decade
- •AST / ALT> 3.5 times higher than the upper reference value
- •bilirubine> 2.0 mg / dl
- •Patients without a history of varicella or without vaccination against varicella zoster virus (VZV) and VZV negative antibody serology
- •Pregnancy or lactation
研究者
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