Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT02373995
Eligibility Criteria:
Inclusion Criteria:
* Group A: Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment)
* definition hyperthyroidism: TSH decreased, FT4 and /or FT3 increased
* definition Graves': diffusely enlarged thyroid gland either by palpation or echograpy, and/or homogeneous thyroid uptake at scintigraphy, or positive TSHRAb
* first episode or recurrence of Graves' hyperthyroidism
* minimal or no eye signs, defined as lid retraction / lid lag but no other signs.
Planned treatment with antithyroid drugs either titration regimen or block-and-replace regimen for 18 months.
Group B. Untreated Graves' hyperthyroidism (or within 4 weeks of initiating ATD treatment) with overt signs of GO as defined by EUGOGO1
1. Mild GO: patients whose features of GO have only a minor impact on daily life insufficient to justify immunosuppressive or surgical treatment. They usually have only one or more of the following: minor lid retraction (\<2 mm), mild soft tissue involvement, exophthalmos \<3 mm above normal for race and gender, transient or no diplopia, and corneal exposure responsive to lubricants)
2. Moderate-to-severe GO: Patients without sight-threatening GO whose eye disease has sufficient impact on daily life to justify the risks of immunosuppression (if active) or surgical intervention (if inactive). Patients with moderate-to-severe GO usually have any one or more of the following: lid retraction R2 mm, moderate or severe soft tissue involvement, exophthalmos \>3 mm above normal for race and gender, inconstant, or constant diplopia.
3. Sight -threatening GO: Patients with dysthyroid optic neuropathy (DON) and/or corneal
Exclusion Criteria:
* Previous or planned treatment with 131I or thyroidectomy (A\&B); sight threatening GO requiring decompression (B); drugs interfering with the natural course of GO (A\&B): steroids, immunosuppressants, thiazolidinediones, antibiotics / antifungals / antivirals (both topical and systemic for at least 4 weeks prior to recruitment to the study); acute diarrhea illness (gastroenteritis for at least 4 weeks prior to recruitment to the study); Drugs interfering with thyroid function (A\&B): amiodarone, lithium, iodine supplements; Drug or alcohol abuse (A\&B); no informed consent (A\&B); Age less than 18 (A\&B); Pregnancy (A\&B).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02373995
Study Brief:
Protocol Section:
NCT02373995