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NCT02253264 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02253264: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT02253264 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02253264, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Multiple sclerosis (MS) is a chronic inflammatory disorder affecting the central nervous system that is characterized pathologically by focal demyelinating lesions in the brain parenchyma. Meningeal inflammation in MS was first noted in 2004. Ectopic lymphoid follicles were described in the meninges of patients with secondary progressive MS (SPMS) and were thought to correlate with cortical lesions and atrophy (a surrogate marker for disability). Subsequently, inflammation in the meninges has been described in primary progressive MS (PPMS) as well as early relapsing MS. The ectopic lymphoid follicles are composed of B-cells, T follicular helper cells and follicular dendritic cells. Rituximab is a monoclonal antibody against CD-20 (a B-cell marker) that is FDA approved for the treatment of various lymphomas. Intrathecal (IT) rituximab administration has been used in central nervous system (CNS) lymphoma to achieve greater cerebrospinal fluid (CSF) concentrations of rituximab. In MS, IT administration of rituximab could lead to higher CSF rituximab levels resulting in the disruption of meningeal ectopic lymphoid follicles, ultimately reducing cortical lesions and possibly disease progression. The investigators hypothesize that IT rituximab therapy in patients with progressive forms of MS could disrupt ectopic lymphoid follicles in the meninges and thus slow progression of the disease, which is particularly important because there exist no FDA-approved therapies for progressive MS. The investigators hypothesize that using magnetic resonance imaging (MRI) to identify those with enhancing meningeal lesions will provide a biomarker to select patients who might be most likely to respond to IT rituximab and to use these lesions to monitor therapeutic response. The primary aim of this study is to assess the safety of intrathecal administration of rituximab in patients with progressive MS. The secondary aims are to evaluate if IT rituximab leads to a decrease in the quanti
Interventions
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-11 |
| Est. Completion | 2017-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02253264
The ClinicalTrials.gov registry entry for NCT02253264 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 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 Rituximab is the first listed.
NCT02253264 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02253264 about?
NCT02253264 is a clinical study titled "A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients". Multiple sclerosis (MS) is a chronic inflammatory disorder affecting the central nervous system that is characterized pathologically by focal demyelinating lesions in the brain parenchyma. Meningeal inflammation in MS was first noted in 2004. Ectopic lymphoid follicles were described in the meninges...
What is the current status of trial NCT02253264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2014-11. Estimated completion is 2017-08.
What interventions are being tested in trial NCT02253264?
The interventions under investigation include: Rituximab (DRUG).
Who is sponsoring clinical trial NCT02253264?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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