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Treatment Strategy for Patients With RA-ILD

1 de septiembre de 2026 actualizado por: Chinese SLE Treatment And Research Group

Treatment Strategy for Patients With Rheumatoid Arthritis Associated Interstitial Lung Disease

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a multicenter, randomized, controlled clinical trial designed to evaluate the efficacy and safety of tocilizumab and rituximab in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD). A total of 204 eligible participants will be enrolled from 20 centers across China and randomly assigned in a 1:1:1 ratio to one of three treatment arms: (1) tocilizumab in combination with conventional disease-modifying antirheumatic drugs (cDMARDs); (2) rituximab in combination with cDMARDs; or (3) methotrexate added to the participant's pre-existing background immunosuppressive regimen. Each treatment arm will include 68 participants. Participants will be assessed at baseline and at Weeks 4, 12, 24, and 52 following treatment initiation. Efficacy and safety data will be collected throughout the study to evaluate treatment response and tolerability. Safety assessments will include the incidence of adverse events (AEs), serious adverse events (SAEs), treatment discontinuations due to AEs or SAEs, and other clinically relevant safety outcomes.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

204

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Xinping Tian
  • Número de teléfono: +86-13691165939
  • Correo electrónico: tianxp6@126.com

Copia de seguridad de contactos de estudio

  • Nombre: Shangyi Jin
  • Número de teléfono: +86-1367049688
  • Correo electrónico: jinjinboli@sina.com

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Peking Union Medical College Hospital
        • Investigador principal:
          • Xinping Tian
        • Contacto:
      • Beijing, Porcelana
        • China-Japan Friendship Hospital
        • Investigador principal:
          • Xin Lu
        • Contacto:
          • Xin Lu
      • Beijing, Porcelana
        • Xuanwu Hospital, Capital Medical University
        • Contacto:
          • Yi Zhao
        • Investigador principal:
          • Yi Zhao
      • Beijing, Porcelana
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Contacto:
          • Juan Meng
        • Investigador principal:
          • juan meng
      • Changchun, Porcelana
        • China-Japan Union Hospital of Jilin University
      • Chongqing, Porcelana
        • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
        • Contacto:
          • Qinghua Zou
        • Investigador principal:
          • Qinghua Zou
      • Dalian, Porcelana
        • The Second Affiliated Hospital of Dalian Medical University
        • Contacto:
          • Xiaodan Kong
        • Investigador principal:
          • Xiaodan Kong
      • Handan, Porcelana
        • Handan Central Hospital
        • Contacto:
          • Xi Liu
        • Investigador principal:
          • Xi Liu
      • Hangzhou, Porcelana
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Investigador principal:
          • Jing Xue
        • Contacto:
          • Jing Xue
      • Hefei, Porcelana
        • The First Affiliated Hospital of Anhui Medical University
        • Contacto:
          • Shengqian Xu
        • Investigador principal:
          • Shengqian Xu
      • Hohhot, Porcelana
        • Affiliated Hospital of Inner Mongolia Medical University
        • Contacto:
          • Hongbin Li
        • Investigador principal:
          • Hongbin Li
      • Jiujiang, Porcelana
        • Jiujiang No. 1 People's Hospital
        • Contacto:
          • Ju Liu
        • Investigador principal:
          • Ju Liu
      • Lanzhou, Porcelana
        • The Second Hospital of Lanzhou University
        • Contacto:
          • Haili Shen
        • Investigador principal:
          • Haili Shen
      • Nanchang, Porcelana
        • The Second Affiliated Hospital of Nanchang University
        • Investigador principal:
          • Xinwang Duan
        • Contacto:
          • Xinwang Duan
      • Nanjing, Porcelana
        • The First Affiliated Hospital of Nanjing Medical University
        • Investigador principal:
          • Wenfeng Tan
        • Contacto:
          • Wenfeng Tan
      • Nanning, Porcelana
        • The First Affiliated Hospital of Guangxi Medical University
        • Investigador principal:
          • Ling Lei
        • Contacto:
          • Ling Lei
      • Taiyuan, Porcelana
        • Shanxi Bethune Hospital
        • Contacto:
          • Liyun Zhang
        • Investigador principal:
          • Liyun Zhang
      • Xingyi, Porcelana
        • Xingyi People's Hospital
        • Contacto:
          • Houli Liao
        • Investigador principal:
          • Houli Liao
      • Yan’an, Porcelana
        • Affiliated Hospital of Yan'an University
        • Contacto:
          • Yuhong Liu
        • Investigador principal:
          • Yuhong Liu
      • Yinchuan, Porcelana
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contacto:
          • Donggeng Guo
        • Investigador principal:
          • Donggeng Guo
      • Ürümqi, Porcelana
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contacto:
          • Li Luo
        • Investigador principal:
          • Li Luo
    • Henan
      • Luoyang, Henan, Porcelana
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Investigador principal:
          • Xiaofei Shi
        • Contacto:
          • Xiaofei Shi

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Tocilizumab group
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.
Droga: 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.
Comparador activo: Methotrexate group
Methotrexate will be administered orally at a dose of 15 mg once weekly for 52 weeks in combination with stable background immunosuppressive therapy.
Droga: Methotrexate
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
Experimental: Rituximab group
Rituximab will be administered by intravenous infusion at a dose of 1000 mg on Day 0, 1000 mg at Week 2, 500 mg at Week 26, and 500 mg at Week 52, in addition to ongoing treatment with csDMARDs.
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in FVC from baseline to week 52
Periodo de tiempo: week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
week 52±2

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants Experiencing a Composite Clinical Endpoint
Periodo de tiempo: Up to Week 52 (±2 Weeks)
Composite clinical endpoint defined as the occurrence of at least one of the following events: all-cause mortality, hospitalization for any cause, hospitalization due to progression of respiratory disease, or death due to progression of respiratory disease.
Up to Week 52 (±2 Weeks)
Change in FVC % Predicted from Baseline
Periodo de tiempo: Baseline to Week 52 (±2)
Change in Percent Predicted Forced Vital Capacity (FVC % Predicted) from baseline to week 52 (±2).
Baseline to Week 52 (±2)
Change in DLCO from Baseline
Periodo de tiempo: Baseline to Week 52 (±2 Weeks)
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) from Baseline.
Baseline to Week 52 (±2 Weeks)
Change in DLCO % Predicted from Baseline
Periodo de tiempo: Baseline to Week 52 (±2 Weeks)
Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLCO % Predicted) from Baseline
Baseline to Week 52 (±2 Weeks)
Change in Chest HRCT Score from Baseline
Periodo de tiempo: Baseline to Week 52 (±2 Weeks)
Change in the total chest high-resolution computed tomography (HRCT) score, inflammatory activity score, and fibrosis score.
Baseline to Week 52 (±2 Weeks)
Change in mMRC Dyspnea Scale Score from Baseline
Periodo de tiempo: Baseline to Week 52 (±2 Weeks)
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score from Baseline to Week 52 (±2). The mMRC Dyspnea Scale is scored from 0 to 4, with higher scores indicating more severe dyspnea.
Baseline to Week 52 (±2 Weeks)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Chinese SLE Treatment And Research Group

Investigadores

  • Investigador principal: Xinping Tian, Peking Union Medical College Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

20 de septiembre de 2026

Finalización primaria (Estimado)

31 de julio de 2029

Finalización del estudio (Estimado)

31 de julio de 2029

Fechas de registro del estudio

Enviado por primera vez

7 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de junio de 2026

Publicado por primera vez (Actual)

11 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Strategy on RA-ILD

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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