SIMVASTATIN for Graves' ophthalmopathy

Inclusion criteria

• {"criterion_text":"- 1.\tAge 18-70 years"}
• {"criterion_text":"- 2.\tActive 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)."}
• {"criterion_text":"- 3.\tGraves´ disease with clinical and laboratory euthyroidism •\tafter stopping treatment with anti-thyroid drugs (ATD), or •\tafter at least 2 months treatment with ATD, or •\tat least 6 months after treatment with radioiodine, or •\tafter total thyroidectomy."}

Exclusion criteria

• {"criterion_text":"- 1.\tPregnancy or breast-feeding"}
• {"criterion_text":"- 2.\tPrevious treatment of Graves´ ophthalmopathy"}
• {"criterion_text":"- 3.\tSevere Graves´ ophthalmopathy requiering corticosteroid treatment, retrobulbar irradiation, or orbital decompression surgery"}
• {"criterion_text":"- 4.\tCurrent or previous treatment with diclofenak (for more than 7 consecutive days during the previous 3 months), simvastatin or other statins (during the last 3 months)"}
• {"criterion_text":"- 5.\tAllergy (skin rash or systemic reactions) to NSAID, ASA or statins"}
• {"criterion_text":"- 6.\tCongestive heart failure"}
• {"criterion_text":"- 7.\tRenal insufficiency (glomerular filtration rate <60 ml/min)"}
• {"criterion_text":"- 8.\tASAT or ALAT > 2.5 times the upper limit of the local laboratory"}
• {"criterion_text":"- 9.\tAlcoholism as judged by local criteria"}
• {"criterion_text":"- 10.\tCoagulopathy including treatment with warfarin or new oral anti-coagulation drugs"}
• {"criterion_text":"- 11.\tPrevious or current gastric ulcer"}
• {"criterion_text":"- 12.\tInflammatory bowel disease"}
• {"criterion_text":"- 13.\tDiabetic retinopathy or nephropathy"}
• {"criterion_text":"- 14.\tTrauma during the last 10 days"}

Primary endpoints

• {"endpoint_text":"- 1.\tClinical activity score (CAS) and progression to severe GO after 6 months of treatment with diclofenac, simvastatin or no additional treatment.","definition_or_measurement_approach":"Measured by Clinical Activity Score (CAS); assessment of progression to severe Graves' ophthalmopathy at 6 months following treatment allocation."}

Secondary endpoints

• {"endpoint_text":"- 1.\tModified CAS is better than CAS in discriminating changes in activity score?","definition_or_measurement_approach":"Comparison of Modified CAS versus CAS performance in detecting changes in activity score (methodology not detailed)."}
• {"endpoint_text":"- 2.\tConjunctival thickness with optical coherence tomography after 3 and 6 months treatment with diclofenac, simvastatin or no additional treatment","definition_or_measurement_approach":"Conjunctival thickness measured by optical coherence tomography (OCT) at 3 and 6 months."}
• {"endpoint_text":"- 3.\tQuality of life after 6 months treatment with diclofenac, simvastatin or no additional treatment","definition_or_measurement_approach":"Quality of life assessed at 6 months (specific instrument not specified)."}
• {"endpoint_text":"- 4.\tChanges in TRAb and TPOAb after 3 and 6 months treatment with diclofenac, simvastatin or no additional treatment","definition_or_measurement_approach":"Serological measurement of TRAb and TPOAb at 3 and 6 months."}
• {"endpoint_text":"- 5.\tNovel markers of active ophthalmopathy","definition_or_measurement_approach":"Exploratory assessment of novel biomarkers (markers not specified)."}

Sweden

Earliest CTIS Part Ii Submission Date

16-11-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

16

Number Of Sites

1

Number Of Participants

102

Primary sponsor

Full Name

Region Skane

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden