Ireland
--:--IST
Recruiting Phase 3

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

NCT03131726 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 3
Started
2018-01-26
Last updated
2024-09-25

Condition(s) studied

Graves OphthalmopathyThyroid Associated OphthalmopathyThyroid Associated Orbitopathy

Investigational drug(s) / intervention(s)

Simvastatin 40mg →

Simvastatin 40mg: see arm description

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
Dpt. of Endocrinology, SUS Malmö Malmö Sweden Recruiting
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