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Treatment Strategy for Patients With RA-ILD

1. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

204

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Xinping Tian
  • Telefonnummer: +86-13691165939
  • E-post: tianxp6@126.com

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tocilizumab group
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.
Legemiddel: 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.
Aktiv komparator: 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.
Legemiddel: Methotrexate
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
Eksperimentell: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in FVC from baseline to week 52
Tidsramme: week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
week 52±2

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Participants Experiencing a Composite Clinical Endpoint
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chinese SLE Treatment And Research Group

Etterforskere

  • Hovedetterforsker: Xinping Tian, Peking Union Medical College Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. september 2026

Primær fullføring (Antatt)

31. juli 2029

Studiet fullført (Antatt)

31. juli 2029

Datoer for studieregistrering

Først innsendt

7. juni 2026

Først innsendt som oppfylte QC-kriteriene

7. juni 2026

Først lagt ut (Faktiske)

11. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Strategy on RA-ILD

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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