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