NCT06567197招募中不适用
Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A Long-term Prospective Observational Study in the Netherlands
Amsterdam UMC, location VUmc2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年8月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Treatment efficacy
研究概览
简要总结
The goal of this observational study is to study the long-term effects of autologous hematopoietic stem cell transplantation (aHSCT) in people with highly active relapsing-remitting multiple sclerosis. The study will evaluate the following items:
- Disease activity
- Safety and tolerability of aHSCT
- Changes in the immune system
Participants will be subjected to frequent visits for five years after treatment with aHSCT. During these visits, clinical testing, evaluation by questionnaires, MRI scans and blood sampling will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS
排除标准
- •Contra-indications for treatment with aHSCT such as known hypersensitivity to the medication used for aHSCT
- •Clinically relevant comorbidities preventing safe use of medication used for aHSCT
- •Severe clinical depression
- •Active addiction to drugs or alcohol
- •Active infections such as but not limited to tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes simplex, varicella zoster, viral hepatitis, toxoplasmosis, HIV or syphilis.
- •Active malignancy or history of malignancy with the exception of local basal cell carcinoma or carcinoma in situ of the cervix
结局指标
主要结局
Treatment efficacy
时间窗: 2 years
The proportion of patients with ne evidence of disease activity-3 (NEDA-3) as defined by: no clinical relapse, no disability progression, no radiological disease activity.
次要结局
- Annual relapse rate(2 years)
- Progression independent of relapse activity (PIRA)(2 years)
- Side-effects and toxicity(2 years)
- Hospital Anxiety and Depression Scale (HADS)(2 years)
- Time to first relapse(2 years)
- EuroQoL 5D (EQ-5D-5L)(2 years)
- Biomarkers(2 years)
- Proteomics(2 years)
- Immune phenotyping(2 years)
- Modified Fatigue Impact Scale (MFIS-5)(2 years)
- iMTA Productivity Cost Questionnaire (iPCQ)(2 years)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(2 years)
- Confirmed disability progression (CDP)(2 years)
- Confirmed disability improvement (CDI)(2 years)
- Brain/spinal cord MRI(2 years)
- Multiple Sclerosis Impact Scale-29 (MSIS-29)(2 years)
- Changes on the multiple sclerosis functional composite (MSFC)(2 years)
- Optical coherence tomography (OCT)(2 years)
- iMTA Medical Cost Questionnaire (iMCQ)(2 years)
- Genetic analysis(2 years)
研究者
Joep Killestein
Clinical Professor
Amsterdam UMC, location VUmc
研究点 (2)
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