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NCT03906227 · ClinicalTrials.gov registry record · NA
Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT03906227 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 9 participants.
The verdict
NCT03906227, a NA study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
ANCA vasculitis is a pauci-immune systemic small vessel vasculitis. The anti-neutrophilic cytoplasmic antibodies (ANCA) are pathogenic and cause disease by activating neutrophils which damage blood vessels. CD means "cluster of differentiation" . CD5 is a type I transmembrane protein found on T cells, thymocytes, and some B cells. Cluster of Differentiation 20 (CD20) is a type III transmembrane protein found on B cells. The investigators previously detected an association between recovery of Interleukin 10 (IL-10)-secreting CD20+ and CD5+ regulatory B cells after immunotherapy (with rituximab and corticosteroids) and decreased risk of subsequent relapse in patients with ANCA-vasculitis. The investigators hypothesize that patients with complete reconstitution of a functional regulatory B cell repertoire after induction therapy are at low risk of relapse and may be monitored conservatively without further immunotherapy. The investigators will test this hypothesis through a proof of concept randomized controlled study. Patients with normalization of CD5+ regulatory B cells will be randomized to maintenance therapy with rituximab vs. close observation without immunosuppression. Patients whose peripheral CD5+ regulatory B cells remain low after induction therapy (who are at higher risk of relapse), will receive maintenance immunosuppression with rituximab. Patients needing or randomized to maintenance therapy who are unable to receive rituximab will receive azathioprine or mycophenolate mofetil, two standard alternative medications for maintenance immunosuppression.
Interventions
- DEVICE ENUMERATION OF CD5+ B Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-06-28 |
| Est. Completion | 2025-02-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03906227
The ClinicalTrials.gov registry entry for NCT03906227 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ENUMERATION OF CD5+ B Cells is the first listed.
NCT03906227 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03906227 about?
NCT03906227 is a clinical study titled "Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis". ANCA vasculitis is a pauci-immune systemic small vessel vasculitis. The anti-neutrophilic cytoplasmic antibodies (ANCA) are pathogenic and cause disease by activating neutrophils which damage blood vessels. CD means "cluster of differentiation" . CD5 is a type I transmembrane protein found on T cell...
What is the current status of trial NCT03906227?
This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2019-06-28. Estimated completion is 2025-02-27.
What interventions are being tested in trial NCT03906227?
The interventions under investigation include: ENUMERATION OF CD5+ B Cells (DEVICE).
Who is sponsoring clinical trial NCT03906227?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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