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Clinical Trials in China / NCT07643038
Starting soon Phase 4

Treatment Strategy for Patients With RA-ILD

NCT07643038 · tracked via the Priya Life Science China tracker
Sponsor
Chinese SLE Treatment And Research Group
Phase
Phase 4
Started
2026-09-20
Last updated
2026-09-03

Condition(s) studied

Rheumatoid Arthritis Associated Interstitial Lung Disease

Investigational drug(s) / intervention(s)

TocilizumabRituximab (RTX)Methotrexate

Tocilizumab: Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks in addition to stable background csDMARD therapy maintained throughout the study period.

Rituximab (RTX): Rituximab will be administered intravenously at a dose of 1,000 mg on Day 0, 1,000 mg at Week 2, 500 mg at Week 26, and 500 mg at Week 52, in addition to stable background csDMARD therapy maintained throughout the study period.

Methotrexate: Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy

Study summary

This is a 52-week, multicenter, prospective, open-label, randomized controlled clinical study, comparing the efficacy and safety of tocilizumab, rituximab, and csDMARD methotrexate in patients with RA-ILD.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Fulfillment of the 2010 ACR/EULAR classification criteria for RA. * HRCT findings consistent with interstitial lung disease (ILD), including ground-glass opacities, reticular abnormalities, fibrotic linear opacities, traction bronchiectasis, or other compatible features, with pulmonary infection, cardiogenic pulmonary edema, and alveolar hemorrhage excluded. The extent of ILD involvement must be ≥20% on HRCT, as assessed by central review. * Pulmonary function impairment defined as forced vital capacity (FVC) \<80% of predicted and/or diffusing capacity of the lung for carbon monoxide (DLCO) \<70% of predicted. * Participants receiving glucocorticoids prior to enrollment must be on a stable dose of prednisone ≤10 mg/day (or equivalent) for at least 4 weeks before baseline. * Participants receiving a csDMARD prior to enrollment must be on a stable regimen for at least 4 weeks before baseline. * Able and willing to provide written informed consent and comply with study requirements, including scheduled visits and follow-up assessments. Exclusion Criteria: * Presence of other autoimmune diseases. * Presence of severe, uncontrolled clinically significant organ dysfunction or other medical conditions that, in the investigator's judgment, would place the participant at unacceptable risk. * History of malignancy within 5 years prior to screening. * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study period. * Known hypersensitivity to tocilizumab, telitacicept, methotrexate, or any of their excipients. * Active hepatitis B or C virus infection, active tuberculosis, active herpes zoster infection, or a history of serious infection within 12 weeks prior to study treatment initiation (defined as an infection requiring hospitalization or intravenous antimicrobial therapy). * Severe hypoalbuminemia or serum immunoglobulin G (IgG) level \<6 g/L. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × the upper limit of normal (ULN), total bilirubin \>1.5 × ULN, or creatinine clearance (CrCl) \<60 mL/min. * Participation in another interventional clinical trial within 4 weeks prior to screening. * Inability to adequately perform pulmonary function testing or other study-related assessments. * Any other condition that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
Beijing Chao-Yang Hospital, Capital Medical University Beijing China
China-Japan Friendship Hospital Beijing China
Peking Union Medical College Hospital Beijing China
Xuanwu Hospital, Capital Medical University Beijing China
China-Japan Union Hospital of Jilin University Changchun China
The First Affiliated Hospital of Army Medical University (Southwest Hospital) Chongqing China
The Second Affiliated Hospital of Dalian Medical University Dalian China
Handan Central Hospital Handan China
The Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou China
The First Affiliated Hospital of Anhui Medical University Hefei China
Affiliated Hospital of Inner Mongolia Medical University Hohhot China
Jiujiang No. 1 People's Hospital Jiujiang China
The Second Hospital of Lanzhou University Lanzhou China
The Second Affiliated Hospital of Nanchang University Nanchang China
The First Affiliated Hospital of Nanjing Medical University Nanjing China
The First Affiliated Hospital of Guangxi Medical University Nanning China
Shanxi Bethune Hospital Taiyuan China
The First Affiliated Hospital of Xinjiang Medical University Ürümqi China
Xingyi People's Hospital Xingyi China
Affiliated Hospital of Yan'an University Yan’an China
People's Hospital of Ningxia Hui Autonomous Region Yinchuan China

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07643038 on ClinicalTrials.gov ↗ ← All trials in China