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Treatment Strategy for Patients With RA-ILD

1 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

204

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Xinping Tian
  • Numéro de téléphone: +86-13691165939
  • E-mail: tianxp6@126.com

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Tocilizumab group
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.
Médicament: 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.
Comparateur actif: 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.
Médicament: Methotrexate
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
Expérimental: 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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in FVC from baseline to week 52
Délai: week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
week 52±2

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants Experiencing a Composite Clinical Endpoint
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chinese SLE Treatment And Research Group

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

20 septembre 2026

Achèvement primaire (Estimé)

31 juillet 2029

Achèvement de l'étude (Estimé)

31 juillet 2029

Dates d'inscription aux études

Première soumission

7 juin 2026

Première soumission répondant aux critères de contrôle qualité

7 juin 2026

Première publication (Réel)

11 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Strategy on RA-ILD

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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