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Treatment Strategy for Patients With RA-ILD

1 de setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

204

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Xinping Tian
  • Número de telefone: +86-13691165939
  • E-mail: tianxp6@126.com

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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 Ativo: 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.
Medicamento: 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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in FVC from baseline to week 52
Prazo: week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
week 52±2

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of Participants Experiencing a Composite Clinical Endpoint
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Chinese SLE Treatment And Research Group

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

20 de setembro de 2026

Conclusão Primária (Estimado)

31 de julho de 2029

Conclusão do estudo (Estimado)

31 de julho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

7 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de junho de 2026

Primeira postagem (Real)

11 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Strategy on RA-ILD

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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