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NCT03873389 · ClinicalTrials.gov registry record
Ocrelizumab Effects on the Metabolome in MS
A clinical trial of Multiple Sclerosis, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 25
- Enrollment target
- 1
- Study location
NCT03873389 is a study of Multiple Sclerosis that has completed, run by Johns Hopkins University. The registered enrollment target is 25 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03873389, a study of Multiple Sclerosis, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
- 1
- Study location
Study 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 Oc
Conditions Studied
Interventions
- DRUG Ocrelizumab
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2023-12-05 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03873389
The ClinicalTrials.gov registry entry for NCT03873389 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Ocrelizumab is the first listed.
NCT03873389 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03873389 about?
NCT03873389 is a clinical study titled "Ocrelizumab Effects on the Metabolome in 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. Part...
What is the current status of trial NCT03873389?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2019-06-12. Estimated completion is 2023-12-05.
What conditions does trial NCT03873389 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT03873389?
The interventions under investigation include: Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT03873389?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03873389 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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