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
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

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

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

Study information

Study designMulticentre, randomised, double blinded, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymEUGOGO study C
Study objectivesThe 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) studiedModerately severe Graves' orbitopathy
InterventionTreatment with weekly methylprednisolone intravenous (iv) infusions, total dose 2.5, 5.0 or 7.5 g for 12 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Methylprednisolone
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date21/09/2005
Completion date01/10/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants159
Key inclusion criteria1. 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 criteria1. 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 enrolment21/09/2005
Date of final enrolment01/10/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan