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

Completed

• Conditions: Moderately severe Graves' orbitopathy; Nutritional, Metabolic, Endocrine; Thyrotoxicosis [hyperthyroidism]

• Registration Number: ISRCTN17061437
• Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 159

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

Exclusion Criteria

1. CAS less than 3
2. Clinically relevant optic nerve involvement
3. General contra-indications to glucocorticoid infusions
4. Pregnancy
5. No informed consent
6. Viral hepatitis
7. Liver enzymes increased by a factor of 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified