Treatment Strategy for Patients With RA-ILD
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese SLE Treatment And Research Group
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 groupsSponsors and collaborators
Source ClinicalTrials.gov