Exploring the Effects of B Cell Depletion With Ofatumumab on Immune Cells and Meningeal Lymphatic Drainage in Patients With Demyelinating Diseases - a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change from baseline in Time to Peak (TTP) of the meningeal lymphatic vessels in superior sagittal sinus (mLVs-SSS) to the end of study.
研究概览
简要总结
This is an uncontrolled, prospective, observational cohort study to assess the function of meningeal lymphatic drainage and dynamics of immune cells in patients with relapsing multiple sclerosis (RMS) or Neuromyelitis optica spectrum disorder (NMOSD) after receiving ofatumumab treatment over an observational period of 12 months.
详细描述
This is an uncontrolled, prospective, observational cohort study in patients with RMS or NMOSD who will receive ofatumumab treatment over an observational period of 12 month. Ofatumumab was administrated 20mg by subcutaneous injection on Days 1, 7 and 14 for initial loading, followed by monthly infusion up to 12 months. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) will be performed to assess meningeal lymphatic flow in participants before and after ofatumumab treatment.The change of immune cell landscape in RMS or NMOSD patients after receiving ofatumumab treatment will be monitored by mass cytometry (CyTOF). Assessments also include clinical assessments( clinical relapse rate and EDSS score) and MRI assessments (T2 lesion load, T1 gadolinium enhancing lesion number).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •RRMS subtype according to 2017 McDonald diagnostic criteria
- •Diagnosis of NMOSD according to the 2015 International Panel diagnostic criteria for NMOSD with AQP4-IgG
- •Newly diagnosed with MS/NMOSD and initiating ofatumumab treatment within the next 3 months
排除标准
- •Hypersensitivity to trial medications
- •History of life-threatening reaction to Ofatumumab
- •Acute or uncontrolled chronic medical condition
- •Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, rituximab, ocrelizumab, alemtuzumab, natalizumab, cyclophosphamide, claridbine, etc.)
- •Impaired hearing
- •Claustrophobia
- •300 lbs of greater (weight limit of MRI table)
- •Pregnancy or breastfeeding
- •Sensitivity to imaging agents
- •Contraindications to MRI
- •Use of benzodiazepines, topiramate, doxycycline, mynocicline
研究组 & 干预措施
Ofatumumab
17 RMS patients and 17 NMOSD patients prescribed with Ofatumumab will be enrolled after informed consent.
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Change from baseline in Time to Peak (TTP) of the meningeal lymphatic vessels in superior sagittal sinus (mLVs-SSS) to the end of study.
时间窗: Baseline, Up To 12months (End of Study)
The image of mLVs-SSS in participants will be detected by Dynamic contrast-enhanced MRI (DCE-MRI) before and after ofatumumab treatment.MRI images would be analyzed by three radiologists independently, and each of them is blinded to the patients' information. The obtained DCE-MRI data are interpreted semi-quantitatively to generate TTP.
次要结局
- Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the end of study(Baseline, Up To 12months (End of Study))
- Immune cells landscape over time(Baseline, month 3, month 6, month 12)
- Adjudicated On-trial Annualized Relapse Rate (ARR)(Baseline, Up To 12months (End of Study))
- Percentage of participants with new lesions by MRI assessments from baseline to the end of study(Baseline, Up To 12months (End of Study))
研究者
Chao Zhang
Professor
Tianjin Medical University General Hospital