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Treatment Strategy for Patients With RA-ILD

1 september 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

204

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Tocilizumab group
Tocilizumab will be administered intravenously at a dose of 8 mg/kg every 4 weeks for 52 weeks in combination with csDMARD.
Läkemedel: 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.
Läkemedel: Methotrexate
Methotrexate will be administered orally at a dose of 15 mg once weekly in addition to stable background csDMARD therapy
Experimentell: 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.
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in FVC from baseline to week 52
Tidsram: week 52±2
Change in Forced Vital Capacity (FVC) from Baseline to Week 52 (±2 Weeks)
week 52±2

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of Participants Experiencing a Composite Clinical Endpoint
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chinese SLE Treatment And Research Group

Utredare

  • Huvudutredare: Xinping Tian, Peking Union Medical College Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

20 september 2026

Primärt slutförande (Beräknad)

31 juli 2029

Avslutad studie (Beräknad)

31 juli 2029

Studieregistreringsdatum

Först inskickad

7 juni 2026

Först inskickad som uppfyllde QC-kriterierna

7 juni 2026

Första postat (Faktisk)

11 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Strategy on RA-ILD

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