Comparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy - EUGOGO study C

INTERVENTION: Treatment with weekly methylprednisolone intravenous (iv) infusions, total dose 2.5, 5.0 or 7.5 g for 12 weeks. CONDITION: Moderately severe Graves' orbitopathy ; Nutritional, Metabolic, Endocrine ; Thyrotoxicosis [hyperthyroidism] PRIMARY OUTCOME: 1. Efficacy: improvement in:; 1.1. Lid aperture of at least 3 mm; 1.2. Two or more degrees of class 2 signs; 1.3. Proptosis by at least 2 mm; 1.4. Any duction by at least 8 degrees or improvement in diplopia score; 1.5. CAS by at least 2 points; 1.6. Improvement of 6 or more points on the GO‐QOL scales; 2. Safety: safety score (2 points to each major side effect and 1 point to each minor side effect) SECONDARY OUTCOME: No secondary outcome measures INCLUSION CRITERIA: 1. Graves' hyperthyroidism, euthyroid for at least two months by antithyroid drugs or surgery (at least 6 months if I131 is used) 2. Moderately severe Graves' ophthalmopathy defined as having at least one of the following signs: 2.1. Class 2b‐c 2.2. Mono‐ocular duction less than 30 degrees 2.3. Diplopia Gorman score grade a‐c 3. Active Graves' ophthalmopathy (Clinical Activity Score [CAS] 3 or higher out of 7) 4. No past treatment of the ophthalmopathy except for local measures 5. Aged 18 ‐ 70 years