NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Treatment Strategy for Patients With RA-ILD
Treatment Strategy for Patients With RA-ILD

NCT07643038

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