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

Обзор

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.

Подробное описание

This is a single-center, randomized, open-label, prospective study. Eligible adults with interstitial lung disease associated with antisynthetase syndrome (ASS-ILD) who are treatment-naïve will be randomly assigned to receive either a JAK inhibitor (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) or a calcineurin inhibitor (tacrolimus 0.075 mg/kg/day in two divided doses, or cyclosporine 2-5 mg/kg/day in two divided doses), both in combination with a standard glucocorticoid regimen. The primary endpoint is the 12-month survival rate. Secondary endpoints include changes in lung function, high-resolution CT (HRCT) scores, glucocorticoid dosage reduction, and the proportion of patients achieving low disease activity. Safety and laboratory parameters will be closely monitored throughout the 12-month treatment and follow-up period. Statistical analyses will compare the efficacy and safety profiles between the two treatment arms, and subgroup analyses will be performed to explore potential predictors of treatment response.

Вмешательства

• Препарат JAK Inhibitor
  Oral JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) administered in combination with standard glucocorticoid therapy for 12 months.
• Препарат Calcineurin Inhibitors (CNI)
  Oral calcineurin inhibitors (tacrolimus 0.075 mg/kg/day in two divided doses, or cyclosporine 2-5 mg/kg/day in two divided doses) administered in combination with standard glucocorticoid therapy for 12 months.

Первичные конечные точки

• 12-month survival rate [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Annual decline rate of lung function (FVC% and DLCO%) [Срок оценки: Change from baseline to 12 months]
• Change in HRCT score [Срок оценки: Change from baseline to 12 months]
• Rate of glucocorticoid tapering [Срок оценки: Over 12 months]
• Proportion of patients achieving low disease activity (LDA) [Срок оценки: At 6 months and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07406932 · JAKCNIASSILD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗