Comparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy - EUGOGO study C
ISRCTN | ISRCTN17061437 |
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DOI | https://doi.org/10.1186/ISRCTN17061437 |
Secondary identifying numbers | MEC 05/101; NTR525 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 04/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof W.M. Wiersinga
Scientific
Scientific
Academic Medical Centre
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
w.m.wiersinga@amc.uva.nl |
Study information
Study design | Multicentre, randomised, double blinded, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | EUGOGO study C |
Study objectives | The hypothesis is that cumulative doses of 2.5, 5.0 or 7.5 g methylprednisolone infusions are equally effective in moderately severe Graves' ophthalmopathy, but that the doses differ in the number and severity of side effects. |
Ethics approval(s) | Ethics approval received from the local ethics committee |
Health condition(s) or problem(s) studied | Moderately severe Graves' orbitopathy |
Intervention | Treatment with weekly methylprednisolone intravenous (iv) infusions, total dose 2.5, 5.0 or 7.5 g for 12 weeks. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Methylprednisolone |
Primary outcome measure | 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 measures | No secondary outcome measures |
Overall study start date | 21/09/2005 |
Completion date | 01/10/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 159 |
Key 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 |
Key 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 |
Date of first enrolment | 21/09/2005 |
Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Website | http://www.amc.uva.nl |
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https://ror.org/03t4gr691 |
Funders
Funder type
Other
Expenses are being covered by the individual participating hospitals (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |