EUCTR2018-004557-24-DE进行中（未招募）1 期
Clarifying the mechanism of action of cladribine in relapsing multiple sclerosis - ClaiMS, Cladribine in MS
Westfälische Wilhelms-Universität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Recht u. Drittmittel0 个研究点目标入组 30 人开始时间: 2019年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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. Signed informed consent form (ICF)
- •2. Age 18 to 60 years old (inclusive) as of the date the ICF is signed
- •3. Diagnosis of MS according to the McDonald criteria 2017 and cranial MRI scan demonstrating white matter lesions attributable to MS
- •4. Therapy with cladribine is indicated (according to label)
- •5. EDSS score 0.0 to 6.0 (inclusive)
- •6. Patient did not receive cladribine treatment before and is cladribine treatment naive at time point of inclusion and first blood draw
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Hypersensitivity to the active substance or to any of the excipients of the study medication
- •2. Acute infection
- •3. Infection with human immunodeficiency virus (HIV)
- •4. Active chronic infection (tuberculosis or hepatitis)
- •5. Suspected progressive multifocal leukoencephalopathy (PML) (a baseline magnetic resonance imaging (MRI) should be performed within 3 months before start of treatment with cladribine)
- •6. Varicella zoster virus antibody-negative patients
- •7. Immunocompromised patients, including patients currently receiving immunosuppressive or myelosuppressive therapy
- •8. Patients with significant disposition for infections
- •9. Abnormal lymphocyte count
- •10. Vaccination with live or attenuated live vaccines within 4 to 6 weeks before start of treatment with cladribine and also during and after cladribine treatment until normalization of white blood cell counts
- •11. Moderate or severe renal impairment (creatinine clearance <60 mL/min)
- •12. Patients with impaired liver function (Child-Pugh-Score >6)
- •13. Patients with active malignancies
- •14. Patients with hereditary problems of fructose intolerance
- •15. Pregnancy and breast-feeding
- •16. For female and male patients of reproductive potential: Unwilling to agree to use a highly effective method of contraception (Pearl index <1) within a period of 6 month after the last cladribine treatment.
- •17. Medical, psychiatric, cognitive, or other condition that, in the Investigator´s opinion, compromise the patient´s ability to understand the patient information, to give informed consent, or to complete the study
- •18. Participation in another interventional clinical trial during this trial or within 4 weeks before entry into this trial resp. 5 half-lives of the previously applied investigational medicinal product depending on which period is longer. Simultaneous inclusion of patients in the clinical trial MAGNIFY (EudraCT-No. 2017-002631-42, Sponsor: Merck KgaA) is permitted. There may be other exceptions at the discretion of the (coordinating) investigator.
- •19. Therapy with teriflunomide, ozanimod, ponesimod or fingolimod within 4 weeks before start of treatment with cladribine
- •20. Therapy with natalizumab within 6 weeks before start of treatment with cladribine
- •21. Therapy with mitoxantron, azathioprin, methotrexat, ciclosporin A or cyclophosphamid within 3 months before start of treatment with cladribine
- •22. Therapy with alemtuzumab, rituximab or ocrelizumab within 6 months before start of treatment with cladribine
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