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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChina-Japan Friendship Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • JAK Inhibitor
  • Calcineurin Inhibitors (CNI)

Treatment groups

80 Participants
are divided into 2 treatment groups