Comparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy. EUGOGO study C
Recruiting
- Conditions
- Moderately severe Graves' orbitopathy
- Registration Number
- NL-OMON20884
- Lead Sponsor
- Prof. dr. W.M. WiersingaDept. of Endocrinology and MetabolismAcademic Medical CenterMeibergdreef 91105 AZ AmsterdamT: +31 20 566 6071F: +31 20 691 7682e-mail: w.m.wiersinga@amc.uva.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- 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:
a. class 2b-c
b. mono-ocular duction <30 degrees
c. diplopia Gorman score grade a-c;
3. Active Graves' ophthalmopathy (CAS 3 or higher out of 7);
4. No past treatment of the ophthalmopathy except for local measures;
5. Age 18-70 years.
Exclusion Criteria
1. CAS <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 2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Efficacy<br>Improvement in:<br>a. lid aperture of at least 3 mm<br>b. 2 or more degrees of class 2 signs<br>c. proptosis by at least 2 mm<br>d. any duction by at least 8 degrees or improvement in diplopia score<br>e. CAS by at least 2 points<br>f. improvement of 6 or more points on the GO-QOL scales.<br>2. Safety<br>safety score (2 points to each major side effect and 1 point to each minor side effect).
- Secondary Outcome Measures
Name Time Method