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A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome

RecruitingNAAges 18 Years - 75 YearsAllChina-Japan Friendship Hospital
NCT07406932 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a prospective investigation comparing the efficacy and safety of Janus kinase inhibitors versus calcineurin inhibitors as initial therapy for interstitial lung disease associated with antisynthetase syndrome. The goal is to determine which treatment is more effective at improving lung function and preventing disease progression, while comparing their safety profiles. The findings will help provide clearer treatment guidance for doctors and patients.

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📋 Eligibility rules (as published)
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.
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What it tests

  • JAK Inhibitor
  • Calcineurin Inhibitors (CNI)
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Where

1 site
China-Japan Friendship Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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