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Combined Advanced Targeted Therapy for Inflammatory Bowel Disease

16. juni 2026 opdateret af: Yongquan Shi, Xijing Hospital of Digestive Diseases

Efficacy and Safety of Combined Advanced Targeted Therapy for Inflammatory Bowel Disease: A Prospective, Multicenter, Real-World Study

The aim of this retrospective and prospective observational study is to investigate and compare the real-world effectiveness and safety of different dual-target combination therapies in patients with inflammatory bowel disease (IBD).

The key questions to be addressed are:

In patients with refractory IBD who receive either two biologic agents or one biologic agent plus one small molecule drug, what is the real-world effectiveness and safety of different combination regimens?

The researchers will conduct a retrospective analysis of medical records and electronic health data from patients diagnosed with IBD, and will enroll and document patients receiving combination advanced targeted therapy (CATT) for long-term follow-up. The treatments received by these patients are part of routine first-line clinical care or routine rescue clinical care. All treatment decisions were made by treating clinicians according to the standard of care; the investigator did not assign or modify any therapeutic interventions. Data will be collected during a defined follow-up period to compare the real-world effectiveness and safety profiles of different treatment exposure strategies.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a retrospective and prospective observational cohort study. All described interventions are part of routine clinical care for patients with inflammatory bowel disease (IBD). Treatment decisions were made by treating clinicians according to the standard of care; the investigator did not prospectively assign, modify, or control any therapeutic interventions. Participants did not receive any intervention specifically for the purpose of this study. The study only involves retrospective analysis of existing medical records to compare real-world outcomes between different treatment exposure patterns.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

117

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710005
        • Xijing Hosipital of Digestive Disease

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This is a multicenter, retrospective and prospective cohort study conducted at 4 tertiary inflammatory bowel disease (IBD) centers in China from April 2023 to April 2026. A total of 117 patients with IBD were enrolled. All patients received Combined Advanced Targeted Therapy (either two biologic agents, or one biologic agent together with one small molecule agent).

Beskrivelse

Inclusion Criteria:

  • 1.Patients diagnosed with IBD; 2.Patients treated with upadacitinib at 4 tertiary inflammatory bowel disease (IBD) centers in China from June 2023 to December 2026； 3.Patients with complete and available clinical, endoscopic, and follow-up data； 4.Patients for whom the study was approved by the Institutional Research 5.Ethics Committee and conducted in accordance with the Declaration of Helsinki.

Exclusion Criteria:

  • 1.Patients with hemodynamic instability; 2.Patients with obvious liver and kidney function injury: bilirubin,aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR < 60ml/min or dialysis patients; 3.Patients allergic to biologic agents or small molecule agents; 4.Patients whose primary disease was gastrointestinal malignancy; 5.Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.; 6.Female patients during pregnancy and breastfeeding (including patients with reproductive needs)； 7.Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.); 8.Patients with missing key data for outcome assessment; 9.Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
IBD Patients with Combined Advanced Targeted Therapy
Group/Cohort Description: This retrospective and prospective observational cohort includes patients with inflammatory bowel disease (IBD) who received combination therapy (two biologic agents or one biologic agent and one small molecule agent) in routine clinical practice. All treatment decisions were made by treating clinicians according to the standard of care; the investigator did not assign or modify any therapeutic interventions, and only retrospectively collected and analyzed clinical outcomes from medical records.
Medicin: Combination therapy
Combination therapy in this study is defined as the concurrent use of either two biologic agents, or one biologic agent together with one small molecule agent.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
clinical response/remission rate at week 12.
Tidsramme: week 12
Clinical remission is defined as a Mayo score ≤ 2 with no subscore > 1 and a rectal bleeding subscore of 0;
week 12
Colectomy-free rate within 90 days
Tidsramme: 90 days
The proportion of IBD patients who did not undergo colectomy within 90 days after the Combined Advanced Targeted Therapy
90 days

Sekundære resultatmål

Resultatmål
Tidsramme
Adverse events (AEs) rate
Tidsramme: 90 days
90 days
Endoscopic response/remission rate at week 12
Tidsramme: week 12
week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Xijing Hospital of Digestive Diseases

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

20. april 2023

Primær færdiggørelse (Faktiske)

10. maj 2026

Studieafslutning (Faktiske)

10. juni 2026

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY20232425-F-1-2

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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