NCT00468182已完成不适用
Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Relative gene expression in plasmacytoid dendritic cells (pDCs)
研究概览
简要总结
The purpose of this study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 to 60 year old, inclusive.
- •Diagnosis of a relapsing form of multiple sclerosis as determined by revised McDonald Criteria or at least one clinical demyelinating episode with abnormal brain MRI study based on CHAMPS criteria
- •Expanded disability status scale (EDSS) score less than 6 at entry.
- •Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
排除标准
- •Treatment with corticosteroids within one month prior to the study. Treatment with immunomodulatory drugs within last 3 months prior to the study.
- •No history of treatment with Interferon-beta(IFN-beta) based drugs to exclude the possibility of IFN-beta neutralizing antibodies
- •Any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
- •History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude IFN-beta therapy.
- •Primary Progressive Multiple Sclerosis patients or patients with Secondary Progressive Multiple Sclerosis with lack of recent clinical relapses for more than 2 years
研究组 & 干预措施
1
MS patients or patients with CIS (Clinically isolated syndrome) who decided to be treated with IFN-beta for 3 months (with the option to continue Rx)
干预措施: Interferon-beta 1b (Betaseron) (Drug)
结局指标
主要结局
Relative gene expression in plasmacytoid dendritic cells (pDCs)
时间窗: Change in gene expression in 12 weeks
Gene expression is tested in pDCs separetd from peripheral blood of human subjects at baseline and at 12 weeks
次要结局
未报告次要终点
研究者
Konstantin Balashov
Associate Professor
Rutgers, The State University of New Jersey
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral TherapyChronic Hepatitis B InfectionNCT03210467Beijing Ditan Hospital120
已完成
4 期
Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2Glucose IntoleranceVitamin D DeficiencyDiabetes Mellitus, Type 2NCT01497132Karolinska Institutet44
Unknown
不适用
Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom AllergyHymenoptera Venom AllergyNCT00947908University of Rostock20
已完成
1 期
Effect of IFN-γ on Innate Immune CellsChronic Granulomatous DiseaseNCT02609932University of Colorado, Denver20
进行中（未招募）
不适用
The effect of interferon beta-1a treatment on adaptability of the brain in patients with MSMultiple sclerosisMedDRA version: 14.0Level: PTClassification code 10004504Term: Beta interferon therapySystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-003570-89-NLVU University Medical Center