RecruitingPhase 3

Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)

Sweden80 participantsStarted 2018-01-26

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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)
✕. Allergy (skin rash or systemic reactions) to statins
✕. Congestive heart failure
✕. Renal insufficiency (glomerular filtration rate \<60 ml/min)
✕. ASAT or ALAT \> 2.5 times the upper limit of the local laboratory

What they're measuring

Change in Clinical activity score (CAS) after 6 months

Timeframe: 6 months

Number of patients with progression to severe GO during 6 months

Timeframe: 6 months

Trial details

NCT IDNCT03131726

SponsorLund University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-26

Contact for this trial

Tereza Planck, MD, PhD

+46-733873399 tereza.planck@med.lu.se

View on ClinicalTrials.gov More Graves Ophthalmopathy trials