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Completed NCT07660289

Combined Advanced Targeted Therapy for Inflammatory Bowel Disease

Conditions: IBD (Inflammatory Bowel Disease), Combined Advanced Targeted Therapy, Combination Therapy

Sex: All
Ages: N/A – 75 Years
Healthy volunteers: No
Enrollment: 117
Sponsor: Xijing Hospital of Digestive Diseases

Location: Xijing Hosipital of Digestive Disease Xi'an Shaanxi

Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Patients diagnosed with IBD; 2. Patients treated with Combined Advanced Targeted Therapy at 4 tertiary 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07660289). StuddyBuddy aggregates publicly available trial information.