Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). 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 |
What the finished NCT02253264 record still lists
NCT02253264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.
NCT02253264 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02253264's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia