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Observational Study on the Efficacy and Safety of Tocilizumab in the Real-World Treatment of Refractory Interstitial Pneumonia Associated with Anti-Synthetase Syndrome

Observational Study on the Efficacy and Safety of Tocilizumab in the Real-World Treatment of Refractory Interstitial Pneumonia Associated with Anti-Synthetase Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128650
Enrollment
Unknown
Registered
2026-07-23
Start date
2026-07-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antisynthetase syndrome-associated interstitial lung disease

Interventions

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Tocilizumab group: 1. Aged >=18 years, meeting the 2017 EULAR/ACR classification criteria for anti-synthetase syndrome; 2.Tocilizumab group: 2.HRCT confirmed ILD; 3.Tocilizumab group: 3.Patients who remain active after hormone therapy and have failed to respond to both hormone therapy and one first-line immunosuppressant (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, baricitinib, upadacitinib, etc.); 4.Tocilizumab group: 4.Patients who have received tocilizumab and have signed the informed consent form for tocilizumab use; 5.Control group: 1. Aged >=18 years, meeting the 2017 EULAR/ACR classification criteria for anti-synthetase syndrome; 6.Control group: 2.HRCT confirmed ILD; 7.Control group: 3.Patients who remain active after hormone therapy and have failed to respond to hormone therapy and one first-line immunosuppressant (mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, baricitinib, upadacitinib, etc.);

Exclusion criteria

Exclusion criteria: 1.Tocilizumab group:1.Pregnant or lactating women; 2.Tocilizumab group: 2.Patients with psychiatric disorders; 3.Tocilizumab group: 3.Patients who have undergone lung transplantation; 4.Tocilizumab group: 4.Patients who did not receive tocilizumab; 5.Control group: 1.Pregnant or lactating women; 6.Control group: 2.Patients with psychiatric disorders; 7.Control group: 3. Patients who have undergone lung transplantation; 8.Control group: 4.Patients who received tocilizumab;

Design outcomes

Primary

MeasureTime frame
Baseline vs symptom change over at least 12-24 weeks;Baseline vs. at least 12-24 weeks of symptom and CT changes;

Secondary

MeasureTime frame
Changes before and after IL-6 treatment;Changes in ferritin before and after treatment;Changes before and after FVC treatment;Changes in lactate dehydrogenase before and after treatment;Changes in creatine kinase before and after treatment;Changes in CRP before and after treatment;

Countries

China

Contacts

Public ContactHu Yinan

China-Japan Friendship Hospital

403698131@qq.com+86 10 84206278

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026