Evaluating the Effects of Ocrelizumab on the Circulating Metabolome in Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Global metabolomic profile
研究概览
简要总结
In this observational study, the investigators aim to recruit 50 patients over an 10-12 month period. The investigators will recruit patients with relapsing-remitting MS (based on 2017 McDonald Criteria) beginning treatment with ocrelizumab and fulfilling study inclusion and exclusion criteria. Participants recruited in this study will be participants in the Johns Hopkins MS Precision Medicine Center of Excellence bio-banking protocol which requires collection of serum and plasma at 6-monthly intervals and hence will have blood collection performed prior to Ocrevus start and then at 6, 12, 18 and 24 months following ocrelizumab initiation as part of the bio-banking protocol. All recruited participants will provide written informed consent.
The investigators will collect demographic and clinical characteristics at baseline and update these at follow-up visits. These will include disease duration, co-morbidities, relapses, treatment status and history. The investigators will also collect physiological variables - height and weight at each visit.
All recruited patients will return for follow up visits at 6,12, 18 and 24 months post-ocrelizumab initiation. At each visit patients will undergo the following evaluations - EDSS, MSFC, SDMT, fatigue scale (MFIS), quality of life measure (MS-QOL), depression scale (Beck depression inventory, 2nd version) and Block Food Frequency Questionnaire.
The investigators will then utilize plasma collected at the various time points to perform global metabolomics analysis. This will yield measures of various metabolites in the circulation, including amino acids and metabolites of the amino acids. The investigators will utilize this data to determine the change in the circulating metabolome produced by treatment with ocrelizumab.
Following this the investigators will assess changes in the various clinical measures collected - disability (EDSS, MSFC), cognition (SDMT), mood (BDI-II), fatigue (MFIS) and quality of life (MS-QOL) with Ocrelizumab treatment and correlate these with the changes noted in the metabolome. This approach will allow us to determine whether the metabolic changes are associated with/ could underlie the changes noted in clinical measures.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18-75 years of age
- •Diagnosis of relapsing remitting multiple sclerosis (RRMS) based on 2017 McDonald Criteria
- •Initiating treatment with Ocrelizumab based on decision of the treating physician
- •Able to return for visits every 6 months to Johns Hopkins MS Center
排除标准
- •Presence of additional neuroinflammatory or neurodegenerative disorder
- •Steroids within the past 30 days
- •Other significant metabolic comorbidity - eg: uncontrolled hypothyroidism or diabetes
- •Likely to switch therapy in the following year
- •Previous treatment with rituximab or other chemotherapy agents
研究组 & 干预措施
Ocrelizumab
All participants enrolled in the study. All participants will be receiving the treatment of interest (Ocrelizumab)
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Change in Global metabolomic profile
时间窗: Baseline to 24 months
Change in relative abundance of various metabolites, including amino acids and metabolites of the amino acids, in plasma measured using mass spectrometry
次要结局
- Change in Expanded Disability Status Scale(Baseline to 24 months)
- Change in Multiple Sclerosis Functional Composite score(Baseline to 24 months)
- Change in Modified Fatigue Impact Scale score(Baseline to 24 months)
- Change in Multiple Sclerosis Quality of Life score(Baseline to 24 months.)