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NCT00501748 · ClinicalTrials.gov registry record · Phase 1

Safety and Tolerability of Rituximab in Neuromyelitis Optica

A Phase 1 study of Neuromyelitis Optica, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
2
Study locations

NCT00501748 is a Phase 1 study of Neuromyelitis Optica that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 511-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00501748, a Phase 1 study of Neuromyelitis Optica, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
2
Study locations

Study Summary

The goal of this research study is to investigate whether Rituximab is safe to use in patients suffering from NMO, or who are at high risk for developing NMO. It is thought that NMO is caused by the immune system reacting against the optic nerves and spinal cord. B cells are a part of the immune system that may contribute to the illness. Rituximab is an antibody that depletes B cells. Depletion of these B cells with Rituximab may induce remission of the disease. Because pathological and serological studies suggest that NMO appears to be, at least in part, a B-cell mediated disease Rituximab, is an attractive treatment candidate for this disease.

Conditions Studied

Interventions

  • DRUG Rituximab

Study Locations (2)

California

  • UCSF MS Center , 350 Parnassus Ave , suite #908 - San Francisco

New York

  • The Neurological Institute of New York MS Center - Columbia University Medical Center 710 West 168th Street,

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2004-01
Est. Completion 2010-12
Phase Phase 1

What the Registry Record Tells You About NCT00501748

The ClinicalTrials.gov registry entry for NCT00501748 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 511-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (96% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neuromyelitis Optica appearing as the primary indexed condition, and to 1 intervention - of which Rituximab is the first listed.

NCT00501748 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, New York.

Frequently Asked Questions

What is clinical trial NCT00501748 about?

NCT00501748 is a clinical study titled "Safety and Tolerability of Rituximab in Neuromyelitis Optica". The goal of this research study is to investigate whether Rituximab is safe to use in patients suffering from NMO, or who are at high risk for developing NMO. It is thought that NMO is caused by the immune system reacting against the optic nerves and spinal cord. B cells are a part of the immune sys...

What is the current status of trial NCT00501748?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2004-01. Estimated completion is 2010-12.

What conditions does trial NCT00501748 study?

This clinical trial studies the following conditions: Neuromyelitis Optica.

What interventions are being tested in trial NCT00501748?

The interventions under investigation include: Rituximab (DRUG).

Who is sponsoring clinical trial NCT00501748?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00501748 being conducted?

This trial has 2 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.