Safety and Tolerability of Rituximab in Neuromyelitis Optica

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT00501748
Phase
PHASE1
Status
Completed

Conditions

  • Neuromyelitis Optica

Eligibility Criteria

Sex
ALL
Age
12 Years - 86 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2004
Status verified
Sep 2011
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab

Primary Outcome Measure

Safety and Tolerability of Rituximab in NMO (monitor for any AE during two years of follow up) [ Time Frame: 96 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
UCSF MS Center , 350 Parnassus Ave , suite #908San FranciscoCalifornia94117-
The Neurological Institute of New York MS CenterColumbia University Medical Center 710 West 168th Street,New York10032-

Find similar trials in San Francisco, CA

By research site
UCSF MS Center , 350 Parnassus Ave , suite #908· San Francisco, CAThe Neurological Institute of New York MS Center· Columbia University Medical Center 710 West 168th Street,, NY

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