Actively Recruiting
A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome
Led by China-Japan Friendship Hospital · Updated on 2026-06-03
80
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Janus kinase (JAK) inhibitors compared to calcineurin inhibitors as initial treatments for interstitial lung disease linked to antisynthetase syndrome. This prospective, randomized, open-label study aims to identify which treatment better improves lung function and prevents disease progression, helping doctors and patients make clearer treatment decisions. Eligible adults with this condition who have not received prior treatment will be randomly assigned to one of two groups. One group will take a JAK inhibitor (tofacitinib, baricitinib, or upadacitinib) along with a standard glucocorticoid regimen, while the other will receive a calcineurin inhibitor (tacrolimus or cyclosporine) combined with the same glucocorticoid treatment. Both treatments last for 12 months, with doses given orally and glucocorticoids tapered over time. Participants will be monitored through lung function tests, high-resolution CT scans, and laboratory assessments during treatment and follow-up. The main outcome is the survival rate at 12 months. Researchers will also measure changes in lung function, CT imaging scores, glucocorticoid dose reduction, and disease activity levels. Safety and laboratory parameters will be closely observed throughout the study period, which lasts one year.
CONDITIONS
Brief Title
A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years.
- Meet the 2017 EULAR/ACR diagnostic criteria for antisynthetase syndrome.
- Have interstitial lung disease confirmed by high-resolution computed tomography.
- Active disease needing start or increase of immunosuppressive therapy.
- No prior use of glucocorticoids, immunosuppressants, or biologics.
- Signed informed consent form.
You will not qualify if you...
- Rapidly progressive interstitial lung disease with worsening breathing within 1 month and low oxygenation (PaO2/FiO2 ratio < 250 mmHg).
- Active severe infection, cancer, or major organ failure not controlled.
- Pregnancy or breastfeeding.
- Known contraindications to study drugs.
- Using other immunosuppressants or biologic treatments concurrently.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either a JAK inhibitor or a calcineurin inhibitor, both in combination with a standard glucocorticoid regimen, for their interstitial lung disease associated with antisynthetase syndrome.
Visits scheduled throughout the 12-month treatment period for medication management and safety monitoring
Duration - Up to 12 months after treatment
Participants are monitored for safety and assessed for lung function, disease activity, and glucocorticoid dosage reduction after treatment ends.
Visits at 6 months and 12 months for disease activity assessment and ongoing safety monitoring
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
Q
Qinghong Liu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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