Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Treatment Strategy for Patients With RA-ILD

7. juni 2026 opdateret af: 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, telitacicept, and csDMARD methotrexate in patients with RA-ILD.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multicenter, randomized, controlled clinical trial designed to evaluate the efficacy and safety of tocilizumab and telitacicept 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) telitacicept 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

204

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tocilizumab group
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.
Medicin: 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.
Eksperimentel: Telitacicept group
Telitacicept will be administered by subcutaneous injection at a dose of 160 mg once weekly for 52 weeks in combination with csDMARD.
Medicin: Telitacicept
Telitacicept will be administered by subcutaneous injection at a dose of 160 mg once weekly 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.
Medicin: Methotrexate
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)
Baseline to Week 52 (±2 Weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese SLE Treatment And Research Group

Efterforskere

  • Ledende efterforsker: Xinping Tian, Peking Union Medical College Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. juli 2029

Studieafslutning (Anslået)

31. juli 2029

Datoer for studieregistrering

Først indsendt

7. juni 2026

Først indsendt, der opfyldte QC-kriterier

7. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Strategy on RA-ILD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Reumatoid arthritis-associeret interstitiel lungesygdom

  • University of Bonn
    Rekruttering
    AYLo - Autoimmunitet og tab af Y (AYLo)
    KOL | Sarcoidose | Idiopatiske inflammatoriske myopatier | Reumatoid arthritis (RA) | Bindevævssygdom | Interstitiel lungesygdom (ILD) | Polymyalgia Rheumatica (PMR) | Giant Cell Arteritis (GCA) | Psoriasisgigt (PsA) | Astma bronchiale | Interstitiel lungesygdom på grund af systemisk sygdom (lidelse) | IgG4-relaterede... og andre forhold
    Tyskland
  • Assistance Publique - Hôpitaux de Paris
    Rekruttering
    EACVI -undersøgelse af multimodalitetskardiovaskulær billeddannelse af inflammatoriske hjerte -kar -sygdomme (EACVI-INFLAME)
    Rheumatoid arthritis | Systemisk lupus erythematosus | Systemisk sklerose | Myokarditis | Spondylarthritis | Perikarditis | Sarcoidose | ANCA Associated Vasculitis | Takayasu arteritis | Idiopatiske inflammatoriske myopatier | Behcets sygdom | Stadig sygdom | Tako Tsubo kardiomyopati
    Frankrig

Kliniske forsøg med Tocilizumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Georgia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner