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

ConditionsGraves OphthalmopathyThyroid Associated OphthalmopathyThyroid Associated Orbitopathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLund University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Simvastatin 40mg

    Drug

    see arm description

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: SimvastatinExperimental treatment 1 intervention
Group B: No treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Clinical activity score (CAS) after 6 months

Change in 7-point clinical activity score (CAS) after 6 months treatment with simvastatin or no treatment

Time frame
6 months
2

Number of patients with progression to severe GO during 6 months

Number of patients with progression to severe GO in each group (simvastatin, no treatment) during 6 months treatment

Time frame
6 months

Secondary outcomes

1

Change in Modified Clinical activity score

Change in Modified clinical activity score after 3 and 6 months treatment with simvastatin or no treatment

Time frame
3 and 6 months
2

Optical coherence tomography

Evaluation of conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with simvastatin or no treatment

Time frame
3 and 6 months
3

Quality of life with SF36

Quality of life after 6 months treatment with simvastatin or no treatment assessed with the SF36 questionnaire

Time frame
6 months
4

Quality of life with ThyrPro

Quality of life after 6 months treatment with simvastatin or no treatment assessed with the ThyPro questionnaire

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lund University

Lead sponsor

Region Skane

Collaborator

Source ClinicalTrials.gov
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