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Treatment Strategy for Patients With RA-ILD

1 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

204

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Xinping Tian
  • Telefoonnummer: +86-13691165939
  • E-mail: tianxp6@126.com

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Tocilizumab group
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.
Geneesmiddel: 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.
Actieve vergelijker: 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.
Geneesmiddel: Methotrexate
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
Experimenteel: 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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in FVC from baseline to week 52
Tijdsspanne: week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
week 52±2

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Participants Experiencing a Composite Clinical Endpoint
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Chinese SLE Treatment And Research Group

Onderzoekers

  • Hoofdonderzoeker: Xinping Tian, Peking Union Medical College Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 september 2026

Primaire voltooiing (Geschat)

31 juli 2029

Studie voltooiing (Geschat)

31 juli 2029

Studieregistratiedata

Eerst ingediend

7 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 juni 2026

Eerst geplaatst (Werkelijk)

11 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Strategy on RA-ILD

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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