Health Trials

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tocilizumab
  • Telitacicept
  • Methotrexate

Treatment groups

204 Participants
are divided into 3 treatment groups

Locations

22
The First Affiliated Hospital of Henan University of Science and Technology LuoyangHenan, China
Beijing Chao-Yang Hospital, Capital Medical University Beijing China
China-Japan Friendship Hospital Beijing China
Peking Union Medical College Hospital Beijing China

Sponsors and collaborators

Chinese SLE Treatment And Research Group

Lead sponsor

Source ClinicalTrials.gov