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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT00595335
Eligibility Criteria:
Inclusion Criteria:
* Patients with clinical activity score (CAS) of ≥4 and moderate to severe disease severity, as defined by thyroid eye disease severity scale based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) score
* Euthyroid for at least 6-8 weeks
* No immediate need for decompression surgery
* With disease progression over the previous 1-2 months or without evident improvement in the prior 6 months.
Exclusion Criteria:
* Corticosteroid use in the preceding 4 weeks
* HIV, hepatitis C or hepatitis B infections
* Denied consent for HIV or hepatitis testing
* Mild or inactive Graves' ophthalmopathy
* Orbital radiotherapy within 18 months or orbital surgery within the past year
* Absolute neutrophil count \< 1,500/mm\^3
* Pregnant or nursing patients
* Coronary artery disease, congestive heart failure, significant arrhythmias, significant infection or immunodeficiency, other serious illnesses
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00595335
Study Brief:
Protocol Section:
NCT00595335