Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease

Recruiting

• Conditions: Inflamatory Bowel Disease
• Interventions: Drug: anti-cytokine antibodies; Drug: anti-integrin antibodies

• Registration Number: NCT07181525
• Lead Sponsor: Peking University First Hospital

Brief Summary

Inflammatory bowel disease (IBD) is a group of chronic progressive gastrointestinal diseases that can recur throughout life and for which there is no cure. Biologics, the first line of treatment, are not only expensive, but also 30-50% of patients lack response to this type of drug therapy. However, there is a lack of reliable methods to predict the clinical efficacy of biologics. The aim of this study is to construct a reliable model to predict patients' response to biologics therapy by comprehensively analysing patients' clinical characteristics, biomarkers and other information to guide individualized therapy. In this study, we will collect clinical data from IBD patients at Peking University First Hospital, including but not limited to patients' baseline characteristics, biomarker levels, and efficacy responses, etc. We will establish a complete patient dataset using a cohort study, train and test the dataset by applying correlation analysis, multiple regression analysis, and machine learning algorithms (e.g. neural networks etc), establish and compare the prediction effects of different models The optimal model is selected for encapsulation and developed into a user-friendly clinical prediction tool. This study will contribute to clinical decision making for IBD patients, improve treatment outcomes, and reduce unnecessary healthcare costs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-11
• Study Start: 2025-08-15
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who are clinically diagnosed with IBD in our hospital
• Disease activity is in the active stage
• Receiving biologics after diagnosis
• Have relevant data on clinical evaluation results after receiving biologics treatment

Exclusion Criteria

• IBD patients who have not been treated with biologics after diagnosis
• Patients diagnosed with IBD but also with other autoimmune diseases that require biologics to be treated
• Patients with hematological diseases and other systemic chronic inflammatory diseases involving the intestine Patients with serious complications including malignant tumors and gastrointestinal perforation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAT group	anti-cytokine antibodies	IBD patients treated with cytokine antagonists
IAT group	anti-integrin antibodies	IBD patients treated with integrin antagonists

Primary Outcome Measures

Name	Time	Method
disease activity	up to 8 weeks	For UC patients, the modified Mayo scoring system was used to evaluate the disease activity of UC patients, and the items involved in the score included the number of bowel movements, blood in the stool, endoscopic performance and physician's overall evaluation, and the sum of the scores was \<2 points without a single sub-\>1 is considered to be in remission, ≥ 3 points or a single sub-item\> 2 points are considered active period; For CD patients, the severity of disease activity is assessed using Best's Crohn's disease activity index (CDAI), including the number of loose stools, abdominal pain, general conditions, extraintestinal manifestations and complications, opioid antidiarrheal use, abdominal masses, decreased hematocrit, and weight loss≥\<.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China