Detailed Description: Before any treatment is given, careful eye and thyroid physical examinations will be performed and the patients will have several thyroid blood tests, a test to count the white cells in the blood, and a CT scan of the head and eyes. A close-up photograph of the face will be taken and patients will be given a short questionnaire about how their eyes are feeling and how the eye disease is affecting their quality of life. Each study subject will receive either 2 infusions of rituximab (each 1000 mg; given 2 weeks apart) or 2 intravenous infusions of saline. Patients will return to Rochester 2 weeks after the first intravenous infusion in order to receive the second infusion. They will then return to Rochester four more times; 2 months apart for the first 3 return visits (weeks 8, 16 and 24 following the first infusion) and 6 months later (approximately 52 weeks following the first infusion) for the final visit to have the same blood tests performed. The CT scan will be repeated at 52 weeks. Patients will be assigned to one of these two groups in a random manner (like flipping a coin) and neither they nor the physicians will know until the study is completed whether they received saline or the study drug. Travel and lodging costs for the 4 return visits up to $2,750 with receipts will be reimbursed and all study-related medical costs following enrollment will be covered.Remuneration of $250.00 will be offered at the end of the study.
Inclusion Criteria:
- patients with clinical activity score (CAS) of ≥4 and moderate to severe disease severity, as defined by NOSPECS score
- euthyroid for at least 6-8 weeks
- no immediate need for decompression surgery
Exclusion Criteria:
- corticosteroid use in the preceding 4 weeks
- HIV, hepatitis C or hepatitis B infections
- denied consent for HIV or hepatitis testing
- mild or inactive Graves' ophthalmopathy
- orbital radiotherapy within 18 months or orbital surgery within the past year
- absolute neutrophil count < 1,500/mm3
- pregnant or nursing patients
- coronary artery disease, congestive heart failure, significant arrhythmias, significant infection or immunodeficiency, other serious illnesses
Last updated: 05/09/2013
NCT ID: NCT00595335
IRB Number:06-006130
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