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NCT01212094 · ClinicalTrials.gov registry record · Phase 1
Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Terminated
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01212094: Clinical Trial Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT01212094 is a Phase 1 study that was terminated before completion, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212094, a Phase 1 study, was terminated before completion, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Background: \- Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple sclerosis (MS). The majority of people who have relapsing-remitting MS eventually develop SP-MS. There are currently no effective treatments for SP-MS. Researchers are interested in determining whether the drug rituximab, which is used to treat rheumatoid arthritis and some types of cancer, is able to target certain white blood cells that are thought to play a role in the progression of SP-MS. To ensure that the rituximab will reach the brain and spinal cord, participants will receive it by intravenous drip and by intrathecal injection (through a lumbar puncture into the cerebrospinal fluid). Objectives: \- To evaluate the safety and effectiveness of combined intravenous and intrathecal rituximab in individuals with secondary-progressive multiple sclerosis. Eligibility: \- Individuals between 18 and 65 years of age who have been diagnosed with SP-MS and have been off any form of immunosuppressive therapy for at least 3 months. Design: \- The study will involve a 1-year pretreatment baseline series of visits, followed by a 2-year treatment period. Participants will provide blood samples throughout treatment as directed by the study researchers, and additional studies may be performed during the study period if participants consent to further investigation.
Primary Outcome
This outcome is for interim analysis of the efficacy of B cell depletion from the CSF 3 months after giving rituximab or placebo into the cerebrospinal fluid (CSF). It compares concentration of chemokine CXCL13 before and 3 months after administration of drug into the CSF. We averaged two time-points before treatment (CSF collected 1 year apart, at month -12 and month 0) and compared it to the single time-point (month 3), which was 3 months from the initiation of drug dosing. CXCL13 is released
Interventions
- DRUG Rituximab
- OTHER normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
Why NCT01212094 stopped before completion
NCT01212094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT01212094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01212094 about?
NCT01212094 is a clinical study titled "Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)". Background: \- Secondary-progressive multiple sclerosis (SP-MS) is the chronic phase of multiple sclerosis (MS). The majority of people who have relapsing-remitting MS eventually develop SP-MS. There are currently no effective treatments for SP-MS. Researchers are interested in determining whether ...
What is the current status of trial NCT01212094?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2010-09. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01212094?
The interventions under investigation include: Rituximab (DRUG), normal saline (OTHER).
Who is sponsoring clinical trial NCT01212094?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01212094's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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
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