Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study of Refractory Myasthenia Gravis that has completed, run by University of Vermont. The registered enrollment target is 10 participants. The trial reports 2 study locations across 2 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00619671
The ClinicalTrials.gov registry entry for NCT00619671 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Vermont, which has 162 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.