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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07406932
Eligibility Criteria:
Inclusion Criteria:
Age 18 to 75 years. Meet the 2017 EULAR/ACR diagnostic criteria for Anti-synthetase Syndrome (ASS). Presence of Interstitial Lung Disease (ILD) confirmed by High-Resolution Computed Tomography (HRCT).
Active disease requiring initiation or intensification of immunosuppressive therapy, with no prior use of glucocorticoids, immunosuppressants, or biologics.
Signed informed consent form.
Exclusion Criteria:
Diagnosis of Rapidly Progressive ILD (RP-ILD), defined as worsening dyspnea within 1 month and PaO2/FiO2 ratio \< 250 mmHg.
Active uncontrolled severe infection, malignancy, or major organ failure. Pregnancy or lactation. Contraindications to the study drugs. Concurrent use of other immunosuppressants or biologics.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07406932
Study Brief:
Protocol Section:
NCT07406932