Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
04/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl

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

Publication citations

Additional files

Editorial Notes