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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2024 |
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Main ID: |
NCT03873389 |
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Date of registration:
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12/03/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ocrelizumab Effects on the Metabolome in MS
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Scientific title:
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Evaluating the Effects of Ocrelizumab on the Circulating Metabolome in Multiple Sclerosis (MS) |
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Date of first enrolment:
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June 12, 2019 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03873389 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Pavan Bhargava, MBBS, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Ocrelizumab
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Primary Outcome(s)
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Change in Global metabolomic profile
[Time Frame: Baseline to 24 months]
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Secondary Outcome(s)
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Change in Multiple Sclerosis Functional Composite score
[Time Frame: Baseline to 24 months]
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Change in Multiple Sclerosis Quality of Life score
[Time Frame: Baseline to 24 months.]
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Change in Expanded Disability Status Scale
[Time Frame: Baseline to 24 months]
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Change in Modified Fatigue Impact Scale score
[Time Frame: Baseline to 24 months]
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Secondary ID(s)
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IRB00205181
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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