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Treatment Strategy for Patients With RA-ILD
Treatment Strategy for Patients With RA-ILD
Not Yet RecruitingPhase 4
Sponsor: Chinese SLE Treatment And Research Group
Conditions: Rheumatoid Arthritis Associated Interstitial Lung Disease
Interventions: Tocilizumab, Telitacicept, Methotrexate
Countries: China
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.
Eligibility overview
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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.
Locations (22)
- Luoyang, Henan, China
- Beijing, China
- Beijing, China
- Beijing, China
- Beijing, China
- Changchun, China
- Chongqing, China
- Dalian, China
- Handan, China
- Hangzhou, China
- Hefei, China
- Hohhot, China
- Jiujiang, China
- Lanzhou, China
- Nanchang, China
- Nanjing, China
- Nanning, China
- Taiyuan, China
- Ürümqi, China
- Xingyi, China
- Yan’an, China
- Yinchuan, China