Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLund University
About this trial
In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy treated with simvastatin or no treatment.
Eligibility criteria
Qualifiers
Age 18-70 years
Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu). Exophthalmos up to 24 mm with a disease duration of <18 months (as recorded by the patient)
Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD), or 2 months treatment with ATD, or euthyroid 6 months after treatment with radioiodine, or euthyroid after total thyroidectomy. Clinical and laboratory euthyroidism is defined as normal fT4, fT3 and TSH below the upper limit of the local reference interval and no clinical symptoms or signs of hyperthyroidism. L-thyroxine is used to achieve euthyroidism during the study period.
Disqualifiers
Pregnancy or breast-feeding
Previous treatment of Graves´ ophthalmopathy
Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery
Current or previous treatment with simvastatin or other statins (within 3 months)
Trial design
Treatments tested in this trial
- Simvastatin 40mg
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lund University
Lead sponsor
Region Skane
Collaborator
Source ClinicalTrials.gov