Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) with Atorvastatin (ATORGO)

Conditions

Graves Ofthalmopathy

Brief summary

The proportion of patients developing active GO after 12 months, defined as a Clinical Activity Score (CAS) ≥3. CAS is a standardized method for assessing the activity of GO.

Detailed description

Proportion of patients developing clinical GO at 3, 6, 9, 15, and 18 months., Time from GD diagnosis to GO onset., Highest CAS recorded during the study period., Proportion of patients requiring interventions such as corticosteroids, orbital irradiation, or biologics (e.g., rituximab or teprotumumab)., Change in quality-of-life scores as measured by validated tools, including GO-QoL and Thyr-Pro questionnaires, at baseline, 12 months, and 18 months., Levels of TSH-receptor antibodies (TRAb) at 12 and 18 months, Identification of new GO-related biomarkers using proteomics and microarray analysis., Genetic differences between responders and non-responders to atorvastatin, identified via genome-wide association studies (GWAS) and analyses of relevant single nucleotide polymorphisms (SNPs).

Related papers

No related papers found yet.

Interventions

DRUGAtorvastatin Viatris 40 mg Filmtabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of patients developing active GO after 12 months, defined as a Clinical Activity Score (CAS) ≥3. CAS is a standardized method for assessing the activity of GO.	—

Secondary

Measure	Time frame
Proportion of patients developing clinical GO at 3, 6, 9, 15, and 18 months., Time from GD diagnosis to GO onset., Highest CAS recorded during the study period., Proportion of patients requiring interventions such as corticosteroids, orbital irradiation, or biologics (e.g., rituximab or teprotumumab)., Change in quality-of-life scores as measured by validated tools, including GO-QoL and Thyr-Pro questionnaires, at baseline, 12 months, and 18 months., Levels of TSH-receptor antibodies (TRAb) at 12 and 18 months, Identification of new GO-related biomarkers using proteomics and microarray analysis., Genetic differences between responders and non-responders to atorvastatin, identified via genome-wide association studies (GWAS) and analyses of relevant single nucleotide polymorphisms (SNPs).	—

Measure

Time frame

Proportion of patients developing clinical GO at 3, 6, 9, 15, and 18 months., Time from GD diagnosis to GO onset., Highest CAS recorded during the study period., Proportion of patients requiring interventions such as corticosteroids, orbital irradiation, or biologics (e.g., rituximab or teprotumumab)., Change in quality-of-life scores as measured by validated tools, including GO-QoL and Thyr-Pro questionnaires, at baseline, 12 months, and 18 months., Levels of TSH-receptor antibodies (TRAb) at 12 and 18 months, Identification of new GO-related biomarkers using proteomics and microarray analysis., Genetic differences between responders and non-responders to atorvastatin, identified via genome-wide association studies (GWAS) and analyses of relevant single nucleotide polymorphisms (SNPs).

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Outcome results

None listed