No registrations found.
ID
Source
Brief title
Health condition
Moderately severe Graves' orbitopathy
Sponsors and support
Dept. of Endocrinology and Metabolism
Academic Medical Center
Meibergdreef 9
1105 AZ Amsterdam
T: +31 20 566 6071
F: +31 20 691 7682
e-mail: w.m.wiersinga@amc.uva.nl
Intervention
Outcome measures
Primary outcome
1. Efficacy
Improvement in:
a. lid aperture of at least 3 mm
b. 2 or more degrees of class 2 signs
c. proptosis by at least 2 mm
d. any duction by at least 8 degrees or improvement in diplopia score
e. CAS by at least 2 points
f. 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
N/A
Background summary
Comparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy. EUGOGO study C
Study objective
The hypothesis is that cummulative doses of 2.5, 5.0 or 7.5 gram methylprednisolone infusions are equally effective in moderately severe Graves' ophthalmopathy, but that the doses differ in the number and severity of side effects.
Intervention
Treatment with weekly methylprednisolone iv infusions, total dose 2.5, 5.0 or 7.5 gram during 12 weeks
P.O. Box 22660
W.M. Wiersinga
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.m.wiersinga@amc.uva.nl
P.O. Box 22660
W.M. Wiersinga
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.m.wiersinga@amc.uva.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL483 |
| NTR-old | NTR525 |
| Other | : MEC 05/101 |
| ISRCTN | ISRCTN17061437 |