NCT07643038
Treatment Strategy for Patients With RA-ILD
Not Yet Recruiting · Phase 4 · Chinese SLE Treatment And Research Group · registry updated 2026-09-03
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
- 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).