Contact information
Type
Scientific
Primary contact
Prof W.M. Wiersinga
ORCID ID
Contact details
Academic Medical Centre
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
w.m.wiersinga@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC 05/101; NTR525
Study information
Scientific title
Acronym
EUGOGO study C
Study hypothesis
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
Ethics approval received from the local ethics committee
Study design
Multicentre, randomised, double blinded, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Methylprednisolone
Primary outcome measures
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 trial start date
21/09/2005
Overall trial end date
01/10/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
159
Participant 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
Recruitment start date
21/09/2005
Recruitment end date
01/10/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Expenses are being covered by the individual participating hospitals (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary