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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Qinghong Liu, MD
166618530@qq.com
+86 15774917676
Time Frame
Start Date: 2026-05-18
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 80
Treatments
Experimental: JAK inhibitor group
Participants in this arm will receive one of the JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) in combination with a standard glucocorticoid regimen (methylprednisolone 0.5g IV for 3 days, followed by oral prednisone 0.8-1.0 mg/kg/day tapered to 7.5 mg/day over 12 months). Treatment duration is 12 months.
Experimental: Calcineurin inhibitor group
Participants in this arm will receive either tacrolimus (0.075 mg/kg/day in two divided doses) or cyclosporine (2-5 mg/kg/day in two divided doses) in combination with the same standard glucocorticoid regimen as the experimental group. Treatment duration is 12 months.
Sponsors
Leads: China-Japan Friendship Hospital

This content was sourced from clinicaltrials.gov

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