EUCTR2019-001960-31-FI进行中（未招募）1 期
Effect of cladribine treatment on microglial activation in the CNS
Turku PET centre0 个研究点目标入组 15 人开始时间: 2019年7月11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
- 15
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
入选标准
- •-Signing the informed consent form
- •-Cladribine treatment is planned and indicated and is according to label
- •-45-55 years of age at the time of signing the research informed consent form
- •-RRMS diagnosis in accordance with McDonald 2017 criteria
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with other neurodegenerative disease than MS
- •-Abnormal lymphocyte counts
- •-Patients with human immunodeficiency virus (HIV).
- •-Patients with active chronic infection (tuberculosis or hepatitis).
- •-Patients with active malignancy.
- •-Patients with moderate or severe renal impairment (creatinine clearance <60 mL/min)
- •-Patients that are pregnant or breast-feeding
- •-Corticosteroid treatment within 4 weeks of imaging
- •-Patients with significant abnormal findings other than MS in a previous MRI.
- •-Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
- •-Contraindication to PET scan investigations
- •-Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
- •-Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.
- •-Patients with previous alemtuzumab administration
- •-Patients with less than 6 months since previous administration of ocrelizumab or rituximab (or with abnormal B-cell counts)
- •-Patients with less than 1 month since previous administration of other DMT
研究者
相似试验
进行中（未招募）
不适用
Effect of Cladribine Treatment on Microglial Activation in the CNSMultiple SclerosisNCT04239820Turku University Hospital15
进行中（未招募）
4 期
Clarifying the mechanism of action of cladribine in relapsing multiple sclerosisMedDRA - 10028245G35.1DRKS00017583Westfälische Wilhelms-Universität Münster24
进行中（未招募）
1 期
Clarifying the mechanism of action of cladribine in relapsing multiple sclerosisMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple SclerosisEUCTR2018-004557-24-DEWestfälische Wilhelms-Universität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Recht u. Drittmittel30
已完成
1 期
Effects of Cladribine Tablets on the PK of Microgynon®Relapsing Multiple Sclerosis (RMS)NCT03745144Merck KGaA, Darmstadt, Germany28
进行中（未招募）
4 期
Effects of Oral Cladribine on Remyelination and Inflammation in Multiple Sclerosis PatientsMultiple Sclerosis, Relapsing-RemittingNCT05902429Pontificia Universidade Católica do Rio Grande do Sul10