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Completed

NCT Number: NCT07660289

Combined Advanced Targeted Therapy for Inflammatory Bowel Disease

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.

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Key information

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710005, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with IBD;
  • Patients treated with Combined Advanced Targeted Therapy at 4 tertiary IBD centers in China from June 2023 to December 2026.
  • Patients with complete and available clinical, endoscopic, and follow-up data;
  • 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.

Treatment and study plan

Combination therapy

Drug

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.

Primary outcomes

  1. clinical response/remission rate at week 12.

    Time frame: week 12

    Clinical remission is defined as a Mayo score ≤ 2 with no subscore > 1 and a rectal bleeding subscore of 0;

  2. Colectomy-free rate within 90 days

    Time frame: 90 days

    The proportion of IBD patients who did not undergo colectomy within 90 days after the Combined Advanced Targeted Therapy

Secondary outcomes

  1. Adverse events (AEs) rate

    Time frame: 90 days

  2. Endoscopic response/remission rate at week 12

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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