Safety and Tolerability of Rituximab in Neuromyelitis Optica

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Neuromyelitis Optica
Interventions
DRUG

Rituximab

Rituximab is a highly purified, 1328-amino acid antibody with an approximate molecular mass of 145 kD. Rituximab is a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration. Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials. In this single arm study all subjects are treated with two cycles of rituximab. Each cycle consists of two 1000 mg infusions administered two weeks apart. The cycles of rituximab treatment are administered at baseline and at 9 months.

Trial Locations (2)

10032

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

94117

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

University of California, San Francisco

OTHER