Starting soon
Phase 4
Treatment Strategy for Patients With RA-ILD
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
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)
- Change in FVC from baseline to week 52 — week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
Trial sites (22)
| Facility | City | Region | Status |
| 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 |
|
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