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NCT03853746 · ClinicalTrials.gov registry record · Phase 4
Short-term B-cell Depletion in Relapsing Multiple Sclerosis
A Phase 4 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT03853746: Completed Phase 4 study, sponsored by Johns Hopkins University.
NCT03853746 is a Phase 4 study that has completed, run by Johns Hopkins University. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03853746, a Phase 4 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
Several disease-modifying therapies (DMTs) have been shown to be effective in reducing the disease activity in patients with relapsing forms of multiple sclerosis (MS) but these treatments, often need to be used continuously for an unknown duration, rendering the long-term use extremely expensive. In addition, chronic administration of DMTs is often associated with undesirable side effects. Among these medications, B-cell depleting monoclonal antibodies might have the properties of an ideal group of medications: i) B-cell depleting antibodies have proven to be extremely potent in reducing or stopping the disease activity in relapsing MS, ii) B-cell depleting antibodies are very safe if used for a short period and use for a short duration may stop the inflammatory disease activity over long term, although current clinical practice and protocols are based on continuing B-cell depletion for an unknown period of time. Indeed, early phase clinical trials of rituximab and ocrelizumab suggested that a short course treatment with B-cell depleting antibodies can have long term effects and disease activity will not return even long after B-cell repopulation in the blood. This long-term effect might be related to the specific pattern of B-cell tolerance defect in patients with MS and the potential of its normalization with B-cell depleting antibodies. By analyzing the reactivity of recombinant antibodies expressed from single B-cells, the investigators' collaborators have demonstrated that the pattern of B-cell tolerance defect is different in people with MS who only display an impaired removal of developing autoreactive B-cells in the periphery while central B-cell tolerance in the bone marrow is functional in most patients. In contrast, patients with rheumatoid arthritis (RA), type-1 diabetes (T1D) or Sjögren's syndrome (SS) show defective central and peripheral B-cell tolerance checkpoints. As a consequence, while anti-B-cell therapy does not correct defective early B-cell
Interventions
- DRUG Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2024-07-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03853746
The ClinicalTrials.gov registry entry for NCT03853746 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ocrelizumab is the first listed.
NCT03853746 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03853746 about?
NCT03853746 is a clinical study titled "Short-term B-cell Depletion in Relapsing Multiple Sclerosis". Several disease-modifying therapies (DMTs) have been shown to be effective in reducing the disease activity in patients with relapsing forms of multiple sclerosis (MS) but these treatments, often need to be used continuously for an unknown duration, rendering the long-term use extremely expensive. I...
What is the current status of trial NCT03853746?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2019-04-01. Estimated completion is 2024-07-01.
What interventions are being tested in trial NCT03853746?
The interventions under investigation include: Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT03853746?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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