Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease

Inclusion Criteria: * Clinical diagnosis of Graves' disease associated with active TED and a clinical activity score of ≥ 4 * Fewer than 9 months from onset of TED * No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization * Euthyroid or with mild hypo or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels less than 50% above or below the normal limits (every effort should be made to correct the mild hypo- or hyperthyroidism promptly) Exclusion Criteria: * Optic neuropathy * Corneal decompensation unresponsive to medical management * Oral or IV steroid treatment for any non-TED reason in the preceding 3 months * Poorly controlled diabetes * Platelets \< 100 x 10\^9/L * Hemoglobin concentration \> 2 g/dL below the lower limit of normal