Ocrelizumab Effects on the Metabolome in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      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.
    


Intervention name(s): Ocrelizumab
Intervention type(s): Drug
Intervention description(s): Patients who are beginning this medication based on patient's treating physician's recommendation will be enrolled in the study.
Other intervention name(s): Ocrevus
Intervention MeSH terms: Ocrelizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be patients diagnosed with relapsing remitting multiple sclerosis between
        18 and 75 years of age who are being started on ocrelizumab by the treating neurologist,
        are willing to return for visits every six months and do not have any other neurological
        disorder or significant metabolic comorbidity.