No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Lund University · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 18-70 years
2. 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)
3. Graves´ dis…
Inclusion Criteria:
1. Age 18-70 years
2. 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)
3. 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:
1. Pregnancy or breast-feeding
2. Previous treatment of Graves´ ophthalmopathy
3. Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery
4. Current or previous treatment with simvastatin or other statins (within 3 months)
5. Allergy (skin rash or systemic reactions) to statins
6. Congestive heart failure
7. Renal insufficiency (glomerular filtration rate \<60 ml/min)
8. ASAT or ALAT \> 2.5 times the upper limit of the local laboratory
9. Alcoholism as judged by local criteria
10. Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs
11. Previous or current gastric ulcer
12. Inflammatory bowel disease diabetic retinopathy or nephropathy
13. Trauma within 10 days
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