NCT03131726 Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)
| NCT ID | NCT03131726 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Lund University |
| Condition | Graves Ophthalmopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2018-01-26 |
| Primary Completion | 2027-01-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 80 participants in total. It began in 2018-01-26 with a primary completion date of 2027-01-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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´ 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
Contact & Investigator
Tereza Planck, MD, PhD
PRINCIPAL INVESTIGATOR
Lund University and Skåne University Hospital
Frequently Asked Questions
Who can join the NCT03131726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Graves Ophthalmopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03131726 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 80 participants.
Is NCT03131726 currently recruiting?
Yes, NCT03131726 is actively recruiting participants. Contact the research team at tereza.planck@med.lu.se for enrollment information.
Where is the NCT03131726 trial being conducted?
This trial is being conducted at Malmö, Sweden.
Who is sponsoring the NCT03131726 clinical trial?
NCT03131726 is sponsored by Lund University. The principal investigator is Tereza Planck, MD, PhD at Lund University and Skåne University Hospital. The trial plans to enroll 80 participants.