NL-OMON42490已完成4 期
Characterization of the immuno-modulatory effects of Tecfidera in multiple sclerosis patients: exploration of drug mechanism and methodological feasibility. - Characterization immuno-modulatory effects of Tecfidera: feasibility study.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria, MS patients
- •- male and female subjects;
- •- minimal age 18 years at the time of informed consent;
- •- confirmed relapsing remitting multiple sclerosis (RRMS) patients, with:
- •- a diagnosis of RRMS according to the revised McDonald criteria;
- •- a baseline score of 0 to 5.0 on the Expanded Disability Status Scale;
- •- patients on Tecfidera treatment for at least 6 months;
- •- ability to participate, and willingness to give written informed consent and to comply with the study restrictions and protocol requirements.;Inclusion criteria, healthy subjects
- •- healthy male and female subjects;
- •- minimal age of 18 years at the time of informed consent;
- •- ability to participate, and willingness to give written informed consent and to comply with the study restrictions and protocol requirements.
排除标准
- •Exclusion criteria, MS patients
- •- positive test result for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), and/or hepatitis B surface antigen (HbsAg) at screening;
- •- evidence of any active or chronic disease or condition, other than MS (based on medical history, a physical examination, vital signs, 12 lead ECG, haematology, blood chemistry and urinalysis) that could, in the opinion of the investigator, interfere with the conduct of the study or the study objectives, or pose an unacceptable risk to the subject;
- •- a treatment history that includes steroids within one month prior to screening, or any other therapy that in the judgment of the investigator potentially interferes with the study objectives (in case of an insufficient washout period);
- •- body weight < 50 kg.
- •- subject is pregnant or breast feeding;
- •- current substance abuse, including alcohol and drugs;
- •- positive alcohol test or test for drugs of abuse at screening, with the exception of a positive test due to medicinal cannabis use;
- •- previous deuterium administration;
- •- participation in an investigational drug or device study within 3 months prior to screening;
- •- loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening;
- •- unwillingness or inability to comply with the study protocol for any other reason.;Exclusion criteria, healthy subjects
- •- positive test result for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), and/or hepatitis B surface antigen (HbsAg) at screening;
- •- evidence of any active or chronic disease or condition (based on medical history, a physical examination, vital signs, 12 lead ECG, haematology, blood chemistry and urinalysis) that could, in the opinion of the investigator, interfere with the conduct of the study or the study objectives, or pose an unacceptable risk to the subjects;
- •- a treatment history that includes steroids within 1 months prior to screening, or any other therapy that in the judgment of the investigator potentially interferes with the study objectives (in case of an insufficient washout period);
- •- body weight < 50 kg;
- •- subject is pregnant or breast feeding;
- •- current substance abuse, including alcohol and drugs;
- •- positive alcohol test or test for drugs of abuse at screening;
- •- previous deuterium administration;
- •- participation in an investigational drug or device study within 3 months prior to screening;
- •- loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening;
- •- unwillingness or inability to comply with the study protocol for any other reason.
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