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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflamatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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CAT group

IBD patients treated with cytokine antagonists

anti-cytokine antibodies

Intervention Type DRUG

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

IAT group

IBD patients treated with integrin antagonists

anti-integrin antibodies

Intervention Type DRUG

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

Interventions

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anti-cytokine antibodies

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

Intervention Type DRUG

anti-integrin antibodies

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No