Ocrelizumab Effects on the Metabolome in MS
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/15/2019 |
| Start Date: | April 2019 |
| End Date: | October 2022 |
| Contact: | Jesse Ritter, MHS |
| Email: | jritte15@jhmi.edu |
| Phone: | 410-502-2488 |
Evaluating the Effects of Ocrelizumab on the Circulating Metabolome in Multiple Sclerosis (MS)
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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