Safety and Tolerability of Rituximab in Neuromyelitis Optica

Completed · Phase 1

Conditions studied: Neuromyelitis Optica

In brief

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 facts

Study ID

NCT00501748

Run by

University of California, San Francisco

People needed

20

Starts

2004-01-01

Expected to finish

2010-12-01

Last updated by the study team

2011-09-27

Who can join

Age: 12 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Criteria for neuromyelitis optica:
• acute transverse myelitis and optic neuritis occurring within 30 days of each other followed by a second attack of either optic neuritis and/or acute transverse myelitis at least 3 months following the heralding attack OR
• acute transverse myelitis followed by optic neuritis at least 3 months later OR
• optic neuritis followed by acute transverse myelitis at least 3 months later
• Criteria for high risk for neuromyelitis optica:
• recurrent idiopathic recurrent acute transverse myelitis with at least 3 months time between each attack OR
• recurrent bilateral simultaneous optic neuritis with at least 3 months time between each attack.
• Subjects should also have no clinical evidence of disease outside the optic nerve or spinal cord.
• In addition patients should have one major supportive criteria OR two minor supportive criteria:
• Negative brain MRI at onset (Does not meet criteria for multiple sclerosis (Paty, 1998)
• Spinal cord MRI with signal abnormality extending over ≥3 vertebral segments
• CSF pleocytosis of > 50 WBC/mm3 OR > 5 PMNs/mm3
• Minor supportive criteria:
• Bilateral optic neuritis
• Severe optic neuritis with fixed visual acuity worse than 20/200 in at least one eye
• Severe, fixed, attack-related weakness (MRC ≤2) in one or more limbs
• Subjects must have exhibited evidence of treatment failure, defined as at least one attack of either acute transverse myelitis or optic neuritis within six months of screening despite treatment within steroids or other immunomodulatory drug for the preceding attack.
• Able and willing to give written informed consent and comply with the requirements of the study protocol.
• Adequate renal function as indicated by normal serum sodium, potassium, chloride, bicarbonate, creatinine, and blood urea nitrogen studies.
• Adequate liver function, as indicated by normal bilirubin and alkaline phosphatase, and transaminases (AST and ALT) within 2X upper limit of normal.
• Negative serum pregnancy test (for women of child bearing age).
• Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.

You may not qualify if…

• Treatment with broad-spectrum immunosuppressant medications such as cyclophosphamide, mitoxantrone, methotrexate, azathioprine, and cladribine, within 60 days of screening.
• Treatment with any investigational agent within 4 weeks of screening
• Receipt of a live vaccine within 4 weeks prior to randomization
• Previous Treatment with Rituximab (MabThera® / Rituxan®)
• Prior antibody therapy
• History of exposure to clioquinol
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• History of HIV (positive HIV, HIV conducted during screening if applicable)
• History of Hepatitis B and/or Hepatitis C (Hep B/C at screening)
• History of recurrent significant infection or history of recurrent bacterial infections
• Known active bacterial, viral fungal mycobacterial, or other infection or any major episode of infection requiring hospitalization
• Ongoing daily steroid use
• History of drug, alcohol, or chemical abuse within 6 months prior to screening
• Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation
• Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• History of psychiatric disorder

Where it is running

• UCSF MS Center , 350 Parnassus Ave , suite #908 — San Francisco, California, United States
• The Neurological Institute of New York MS Center — Columbia University Medical Center 710 West 168th Street,, New York, United States

Full record on ClinicalTrials.gov

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