Rituximab in the Treatment of Scleritis and Non-Infectious Orbital Inflammation

Exclusion Criteria

• •Untreated thyroid disease
• •Organ threatening systemic disease as evidenced by rapidly progressive glomerulonephritis, pulmonary hemorrhage or respiratory failure, seizures or psychosis, progressive neuropathy or myopathy
• •Patients will be excluded from the study based on the following criteria:
• •Hemoglobin: \< 8.5 gm/dL
• •Platelets: \< 100,000/mm
• •AST or ALT \>2.5 x Upper Limit of Normal unless related to primary disease.
• •Positive Hepatitis B or C serology (Hep B Surface antigen and Hep C antibody)
• •History of positive HIV (HIV conducted during screening if applicable)
• •Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
• •Receipt of a live vaccine within 4 weeks prior to randomization
• •Previous Treatment with Rituximab (MabThera® / Rituxan®)
• •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• •History of recurrent significant infection or history of recurrent bacterial infections
• •Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening
• •Unstable steroid dose in the past 4 weeks
• •Lack of peripheral venous access
• •History of drug, alcohol, or chemical abuse within 6 months prior to screening
• •Pregnancy (a negative serum pregnancy for all women of childbearing potential at screening and negative urine pregnancy test prior to each infusion) or lactation
• •Concomitant or previous malignancies, with the exception of curatively resected non-melanoma skin carcinomas or carcinoma in situ of the cervix
• •History of psychiatric disorder that would interfere with normal participation in this protocol
• •Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
• •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
• •Inability to comply with study and follow-up procedures