Clinical Trials in Sweden / NCT03131726
Recruiting
Phase 3
Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)
NCT03131726 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Graves OphthalmopathyThyroid Associated OphthalmopathyThyroid Associated Orbitopathy
Study 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.
Eligibility
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
Primary outcome measure(s)
- Change in Clinical activity score (CAS) after 6 months — 6 months
Change in 7-point clinical activity score (CAS) after 6 months treatment with simvastatin or no treatment - Number of patients with progression to severe GO during 6 months — 6 months
Number of patients with progression to severe GO in each group (simvastatin, no treatment) during 6 months treatment
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Dpt. of Endocrinology, SUS Malmö | Malmö | Sweden | Recruiting |
More Lund University trials in Sweden
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03131726 on ClinicalTrials.gov ↗ ← All trials in Sweden