B-cell Depletion Therapy With Rituximab for Thyroid Eye Disease

Exclusion Criteria

• •Patients will be excluded from the study based on the following criteria:
• •1. Brittle insulin dependent diabetes \[The term "brittle" refers to cases of diabetes in which there is an instability that leads to a disruption of life and often recurrent and/ or prolonged hospitalization\]
• •2. Pregnant or nursing patients
• •3. Significant medical comorbidities that would make the risk of high dose steroids intolerable such as severe CHF, CAD, arrhythmias, renal insufficiency, infection or immune deficiency, systemic autoimmune disease, severe glaucoma etc.
• •4. Absolute neutrophil count \< 1500/mm³.
• •5. Contraindication to use of rituximab
• •6. Positive PPD and/or Quantiferon Gold TB test without prior anti-tuberculous therapy; active TB
• •7. HIV or hepatitis infection or declined consent for HIV or hepatitis testing
• •8. Use of rituximab in the prior 24 months for any reason other than TED
• •9. Unwillingness to practice birth control for at least 12 months post treatment
• •10. Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment), or lactating.
• •11. Inability to comply with study and/or follow-up procedures.
• •12. History of HIV.
• •13. Presence of active infection.
• •14. Presence of CNS metastases.
• •15. New York Heart Association Classification III or IV heart disease (See Appendix D).
• •16. 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.
• •17. History of psychiatric disorder.
• •18. At the Investigator's discretion, receipt of a live vaccine within 4 weeks prior to randomization.