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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
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.
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
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Change in FVC from baseline to week 52
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
Time frame: week 52±2
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.
Time frame: 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).
Time frame: Baseline to Week 52 (±2)
Change in DLCO from Baseline
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from Baseline.
Time frame: 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
Time frame: 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.
Time frame: 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)
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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
...and 12 more locations
Time frame: Baseline to Week 52 (±2 Weeks)