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.
ID
Bron
Verkorte titel
Aandoening
Moderately severe Graves' orbitopathy
Ondersteuning
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
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
Comparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy. EUGOGO study C
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
Treatment with weekly methylprednisolone iv infusions, total dose 2.5, 5.0 or 7.5 gram during 12 weeks
Publiek
P.O. Box 22660
W.M. Wiersinga
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.m.wiersinga@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
W.M. Wiersinga
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.m.wiersinga@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL483 |
| NTR-old | NTR525 |
| Ander register | : MEC 05/101 |
| ISRCTN | ISRCTN17061437 |