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NCT00619671 · ClinicalTrials.gov registry record · Phase 1
A Pilot Trial of Rituxan in Refractory Myasthenia Gravis
A Phase 1 study of Refractory Myasthenia Gravis, sponsored by University of Vermont.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT00619671: Completed Phase 1 study of Refractory Myasthenia Gravis, sponsored by University of Vermont.
NCT00619671 is a Phase 1 study of Refractory Myasthenia Gravis that has completed, run by University of Vermont. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00619671, a Phase 1 study of Refractory Myasthenia Gravis, has completed, sponsored by University of Vermont.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
Myasthenia gravis is a disease that happens because the immune system attacks the nervous system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage a special part of the muscle that helps transmit impulses from nerves to muscles to allow muscles to work properly. This damage results in symptoms of myasthenia gravis. Participants are being asked to participate in this research study because their myasthenia gravis has either failed to respond to treatments commonly used in the disease, or they have had bad side-effects from such treatments. This is a research study of a drug called Rituximab. Rituximab, also called Rituxan, is a mouse antibody that has been changed to make it similar to a human antibody. Antibodies are proteins that can protect the body from foreign invaders, such as bacteria and viruses, by binding to substances called antigens. Rituxan works by binding to a protein, called the CD20 protein. Rituxan helps to destroy white blood cells that produce antibodies in the body, called B-lymphocytes. It is a treatment given through a vein in the participant's arm over a period of approximately 4-6 hours. It has been approved by the Food and Drug Administration (FDA) for use in patients with a form of cancer of the lymph glands called Non-Hodgkin's Lymphoma (NHL). Rituximab is not approved for their myasthenia gravis. Treatment with Rituximab is being tried in this research study because Rituximab decreases B lymphocytes. There is preliminary evidence that Rituximab helps some patients with chronic and otherwise difficult to treat myasthenia gravis.
Conditions Studied
Interventions
- DRUG Rituximab (Rituxan)
Study Locations (2)
New York
- State University of New York - Syracuse
Vermont
- University of Vermont Department of Neurology - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2004-04 |
| Est. Completion | 2009-03 |
| Phase | Phase 1 |
What the finished NCT00619671 record still lists
NCT00619671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Refractory Myasthenia Gravis appearing as the primary indexed condition, and to 1 intervention - of which Rituximab (Rituxan) is the first listed.
NCT00619671 reports a single indexed study location in New York, Vermont.
Frequently Asked Questions
What is clinical trial NCT00619671 about?
NCT00619671 is a clinical study titled "A Pilot Trial of Rituxan in Refractory Myasthenia Gravis". Myasthenia gravis is a disease that happens because the immune system attacks the nervous system. The damage is caused by antibodies produced by B lymphocytes. These antibodies damage a special part of the muscle that helps transmit impulses from nerves to muscles to allow muscles to work properly. ...
What is the current status of trial NCT00619671?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2004-04. Estimated completion is 2009-03.
What conditions does trial NCT00619671 study?
This clinical trial studies the following conditions: Refractory Myasthenia Gravis.
What interventions are being tested in trial NCT00619671?
The interventions under investigation include: Rituximab (Rituxan) (DRUG).
Who is sponsoring clinical trial NCT00619671?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00619671 being conducted?
This trial has 2 study locations across New York, Vermont. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00619671's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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