A Phase II, pilot clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in hypercholesterolemic patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy.

A Phase II, open-label, ophthalmological external investigator-blinded, single-center, randomized, superiority, no profit, pilot clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in hypercholesterolemic patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy: the STAGO study - STUDIO STAGO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001317-33-IT

Enrollment

Registered

2020-10-07

Start date

2020-05-14

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves’ orbitopathy is a disabling and disfiguring disease affecting the eyes observed in approximately 25-30% of patients with Graves’ disease. Its clinical manifestations include exophthalmos, inflammatory signs and symptoms, diplopia, and in most severe cases sight impairment. MedDRA version: 20.0 Level: PT Classification code 10004161 Term: Basedow's disease System Organ Class: 10014698 - Endocrine disorders

Interventions

Product Name: ATORVASTATINA Product Code: [x] Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ATORVASTATINA Current Sponsor code: NA Other descriptive name: Atorvastatin Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Informed consent ; 2) A diagnosis of Graves’ disease; 3) A moderately severe Graves’ orbitopathy; 4) Active Graves’ orbitopathy; 5) No corticosteroids or immunosuppressive treatment for Graves’ orbitopathy in the last 3 months; 6) No previous surgical treatment for GO; 7) No contraindication to GC; 8) Male and female patients of age: 18-75 years; 9) LDL-cholesterol levels of 115-189 mg/dl; 10) No more than one cardiovascular risk factor; 11) Contraceptive method with a failure rate of less than 1% (patients of childbearing potential); 12) No mental illness ; 13) Compliant patient, regular follow-up possible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 88 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: 1) lack of informed consent; 2) Absence of Graves’ hyperthyroidism; 3) inactive Graves’ orbitopathy; 4) Optic neuropathy; 5) Corticosteroids or immunosuppressive treatment in the last 3 months; 6) Previous surgical treatment for Graves’ orbitopathy; 7) Contraindications to glucocorticoids; 8) Pregnancy, breast-feeding women; 9) Acute or chronic liver disease; 10) Hypersensitivity to atorvastatin or other statins, or hypersensitivity or intolerance to the medication excipients such as lactose; 11) Medications interfering/interacting with statins; 12) Relevant Malignancy; 13) Recent (=1 year) history of alcoholism or drug abuse; 14) Clinical ASCVD (AthroSclerotic CardioVascular Disease); 15) LDL-cholesterol levels =190 mg/dl or presence of more than one associated cardiovascular risk factor;16) Severe familial hyperlipemia

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of atorvastatin treatment on the overall outcome of Graves’ Orbitopathy at 24 weeks, in hypercolesterolemic patients with Graves’ disease and moderately severe, active Graves’ Orbitopathy to be treated with intravenous glucocorticoids .;Secondary Objective: To investigate the effect of atorvastatin treatment on the overall outcome of Graves’ Orbitopathy at 12 weeks (response measure as above). To determine whether atorvastatin reduces the rate of GO relapse at 24 settimane;Primary end point(s): Response rate of GO at 24 weeks: -Comparison of overall GO outcome (stable, improved, worsened) determined using a composite evaluation as indicated below. The evaluation will be performed by a blinded ophthalmologist and will be documented in the source data, i.e. patient’s fill, and the EUGOGO CRF (4), including the following items: - Lid aperture in mm - CAS (4) (7 items) - Exophthalmos in mm using a Hertel exophthalmometer - Eye muscle involvement – diplopia score (Gorman score) - Visual acuity using the Snellen chart in log10 According to the composite evaluation: Improvement is defined as change in two of the following outcome measures in at least one eye, without deterioration in any of the same measures in both eyes (compared to baseline): - -Improvement in CAS by at least 2 points - -Improvement in exophthalmos by at least 2 mm (Hertel exophthalmometer) - -Improvement in lid aperture by at least 2 mm - -Improvement in diplopia (disappearance or change in the degree) - -Improvement of visual acuity by at least 0.2/1 Worsening is defined as change in two of the following outcome measures in at least one eye (compared to baseline): - -Worsening in CAS by at least 2 points - -Worsening of exophthalmos [>2 mm (Hertel exophthalmometer)] - -Worsening of lid aperture by at least 2 mm - -Worsening of diplopia (appearance or change in the degree) - -Worsening of visual acuity by at least 0.2/1 No change is defined as absence of	—

Measure

Time frame

Main Objective: To investigate the effect of atorvastatin treatment on the overall outcome of Graves’ Orbitopathy at 24 weeks, in hypercolesterolemic patients with Graves’ disease and moderately severe, active Graves’ Orbitopathy to be treated with intravenous glucocorticoids .;Secondary Objective: To investigate the effect of atorvastatin treatment on the overall outcome of Graves’ Orbitopathy at 12 weeks (response measure as above). To determine whether atorvastatin reduces the rate of GO relapse at 24 settimane;Primary end point(s): Response rate of GO at 24 weeks: -Comparison of overall GO outcome (stable, improved, worsened) determined using a composite evaluation as indicated below. The evaluation will be performed by a blinded ophthalmologist and will be documented in the source data, i.e. patient’s fill, and the EUGOGO CRF (4), including the following items: - Lid aperture in mm - CAS (4) (7 items) - Exophthalmos in mm using a Hertel exophthalmometer - Eye muscle involvement – diplopia score (Gorman score) - Visual acuity using the Snellen chart in log10 According to the composite evaluation: Improvement is defined as change in two of the following outcome measures in at least one eye, without deterioration in any of the same measures in both eyes (compared to baseline): - -Improvement in CAS by at least 2 points - -Improvement in exophthalmos by at least 2 mm (Hertel exophthalmometer) - -Improvement in lid aperture by at least 2 mm - -Improvement in diplopia (disappearance or change in the degree) - -Improvement of visual acuity by at least 0.2/1 Worsening is defined as change in two of the following outcome measures in at least one eye (compared to baseline): - -Worsening in CAS by at least 2 points - -Worsening of exophthalmos [>2 mm (Hertel exophthalmometer)] - -Worsening of lid aperture by at least 2 mm - -Worsening of diplopia (appearance or change in the degree) - -Worsening of visual acuity by at least 0.2/1 No change is defined as absence of

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Response rate (composite eye evaluation and GO-QoL) 12 weeks after inclusion. 2) GO relapse at 24 weeks (defined as worsening in comparison with the 12 week evaluation).;Timepoint(s) of evaluation of this end point: Secondary endpoints: 12 and 24 weeks	—

Countries

Italy

Contacts

Public ContactU.O. Endocrinologia 1

AOUP

michele.marino@med.unipi.it050997346

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026