Treatment Strategy for Patients With RA-ILD

Treatment Strategy for Patients With Rheumatoid Arthritis Associated Interstitial Lung Disease

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis Associated Interstitial Lung Disease
• Intervention / Treatment: Drug: Tocilizumab; Drug: Telitacicept; Drug: Methotrexate

Detailed Description

This is a multicenter, randomized, controlled clinical trial designed to evaluate the efficacy and safety of tocilizumab and telitacicept in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). A total of 204 eligible participants will be enrolled from 20 centers across China and randomly assigned in a 1:1:1 ratio to one of three treatment arms: (1) tocilizumab in combination with conventional disease-modifying antirheumatic drugs (cDMARDs); (2) telitacicept in combination with cDMARDs; or (3) methotrexate added to the participant's pre-existing background immunosuppressive regimen. Each treatment arm will include 68 participants. Participants will be assessed at baseline and at Weeks 4, 12, 24, and 52 following treatment initiation. Efficacy and safety data will be collected throughout the study to evaluate treatment response and tolerability. Safety assessments will include the incidence of adverse events (AEs), serious adverse events (SAEs), treatment discontinuations due to AEs or SAEs, and other clinically relevant safety outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xinping Tian; Phone Number: +86-13691165939; Email: tianxp6@126.com
• Study Contact Backup: Name: Shangyi Jin; Phone Number: +86-1367049688; Email: jinjinboli@sina.com

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital
    • Principal Investigator: Xinping Tian
    • Contact: Shangyi Jin; Phone Number: +86-13671049688; Email: jinjinboli@sina.com
  • Beijing, China
    • China-Japan Friendship Hospital
    • Principal Investigator: Xin Lu
    • Contact: Xin Lu
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University
    • Contact: Yi Zhao
    • Principal Investigator: Yi Zhao
  • Beijing, China
    • Beijing CHAO-YANG Hospital, Capital Medical University
    • Contact: Juan Meng
    • Principal Investigator: Juan Meng
  • Changchun, China
    • China-Japan Union Hospital of Jilin University
  • Chongqing, China
    • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
    • Contact: Qinghua Zou
    • Principal Investigator: Qinghua Zou
  • Dalian, China
    • The Second Affiliated Hospital of Dalian Medical University
    • Contact: Xiaodan Kong
    • Principal Investigator: Xiaodan Kong
  • Handan, China
    • Handan Central Hospital
    • Contact: Xi Liu
    • Principal Investigator: Xi Liu
  • Hangzhou, China
    • The Second Affiliated Hospital, Zhejiang University School of Medicine
    • Principal Investigator: Jing Xue
    • Contact: Jing Xue
  • Hefei, China
    • The First Affiliated Hospital of Anhui Medical University
    • Contact: Shengqian Xu
    • Principal Investigator: Shengqian Xu
  • Hohhot, China
    • Affiliated Hospital of Inner Mongolia Medical University
    • Contact: Hongbin Li
    • Principal Investigator: Hongbin Li
  • Jiujiang, China
    • Jiujiang No. 1 People's Hospital
    • Contact: Ju Liu
    • Principal Investigator: Ju Liu
  • Lanzhou, China
    • The Second Hospital of Lanzhou University
    • Contact: Haili Shen
    • Principal Investigator: Haili Shen
  • Nanchang, China
    • The Second Affiliated Hospital of Nanchang University
    • Principal Investigator: Xinwang Duan
    • Contact: Xinwang Duan
  • Nanjing, China
    • The First Affiliated Hospital of Nanjing Medical University
    • Principal Investigator: Wenfeng Tan
    • Contact: Wenfeng Tan
  • Nanning, China
    • The First Affiliated Hospital of Guangxi Medical University
    • Principal Investigator: Ling Lei
    • Contact: Ling Lei
  • Taiyuan, China
    • Shanxi Bethune Hospital
    • Contact: Liyun Zhang
    • Principal Investigator: Liyun Zhang
  • Xingyi, China
    • Xingyi People's Hospital
    • Contact: Houli Liao
    • Principal Investigator: Houli Liao
  • Yan’an, China
    • Affiliated Hospital of Yan'an University
    • Contact: Yuhong Liu
    • Principal Investigator: Yuhong Liu
  • Yinchuan, China
    • People's Hospital of Ningxia Hui Autonomous Region
    • Contact: Donggeng Guo
    • Principal Investigator: Donggeng Guo
  • Ürümqi, China
    • The First Affiliated Hospital of Xinjiang Medical University
    • Contact: Li Luo
    • Principal Investigator: Li Luo
  • Henan
    • Luoyang, Henan, China
      • The First Affiliated Hospital of Henan University of Science and Technology
      • Principal Investigator: Xiaofei Shi
      • Contact: Xiaofei Shi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tocilizumab group; Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.	Drug: 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.
Experimental: Telitacicept group; Telitacicept will be administered by subcutaneous injection at a dose of 160 mg once weekly for 52 weeks in combination with csDMARD.	Drug: Telitacicept; Telitacicept will be administered by subcutaneous injection at a dose of 160 mg once weekly in addition to stable background csDMARD therapy maintained throughout the study period
Active Comparator: Methotrexate group; Methotrexate will be administered orally at a dose of 15 mg once weekly for 52 weeks in combination with stable background immunosuppressive therapy.	Drug: Methotrexate; Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FVC from baseline to week 52	Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)	week 52±2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Experiencing a Composite Clinical Endpoint	Composite clinical endpoint defined as the occurrence of at least one of the following events: all-cause mortality, hospitalization for any cause, hospitalization due to progression of respiratory disease, or death due to progression of respiratory disease.	Up to Week 52 (±2 Weeks)
Change in FVC % Predicted from Baseline	Change in Percent Predicted Forced Vital Capacity (FVC % Predicted) from baseline to week 52 (±2).	Baseline to Week 52 (±2)
Change in DLCO from Baseline	Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from Baseline.	Baseline to Week 52 (±2 Weeks)
Change in DLCO % Predicted from Baseline	Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO % Predicted) from Baseline	Baseline to Week 52 (±2 Weeks)
Change in Chest HRCT Score from Baseline	Change in the total chest high-resolution computed tomography (HRCT) score, inflammatory activity score, and fibrosis score.	Baseline to Week 52 (±2 Weeks)
Change in mMRC Dyspnea Scale Score from Baseline	Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score from Baseline to Week 52 (±2)	Baseline to Week 52 (±2 Weeks)

Collaborators and Investigators

• Sponsor: Chinese SLE Treatment And Research Group
• Investigators: Principal Investigator: Xinping Tian, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: June 7, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; Tocilizumab; Telitacicept
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pterins; Pteridines; Aminopterin; Methotrexate; tocilizumab; telitacicept
• Other Study ID Numbers: Strategy on RA-ILD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No