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

NCT07181525 | Recruiting

• 1 other identifier: 2025R0267-0001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflamatory Bowel Disease

Keywords

inflammatory bowel disease; machine learning; biologics

Outcome Measures

Primary Outcomes (1)

• disease activity

  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≥\<.

  up to 8 weeks

Study Arms (2)

CAT group

IBD patients treated with cytokine antagonists

Drug: anti-cytokine antibodies

IAT group

IBD patients treated with integrin antagonists

Drug: anti-integrin antibodies

Interventions

anti-cytokine antibodies DRUG

Different kinds of biologics used to treat inflammatory bowel disease (including anti-cytokine antibodies)

CAT group

anti-integrin antibodies DRUG

Different kinds of biologics used to treat inflammatory bowel disease (including anti-integrin antibodies)

IAT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult inflammatory bowel disease patients in our hospital have no specific selection such as race, gender, or age.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Raphael Hong

CONTACT

+86 (010)83575675; doctoraphael@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 18, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CN (1)