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
DOI	https://doi.org/10.1186/ISRCTN17061437
Protocol serial number	MEC 05/101; NTR525
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Expenses are being covered by the individual participating hospitals (The Netherlands)

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

Prof W.M. Wiersinga
Scientific

Academic Medical Centre
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Email	w.m.wiersinga@amc.uva.nl

Primary study design	Interventional
Study design	Multicentre, randomised, double blinded, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methylprednisolone
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/10/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Academic Medical Centre

Amsterdam
1105 AZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan