Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: anti-cytokine antibodies, anti-integrin antibodies.
- Who it may be relevant to
- Registry conditions: Inflamatory Bowel Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug anti-cytokine antibodies
Different kinds of biologics used to treat inflammatory bowel disease (including anti-cytokine antibodies) - Drug anti-integrin antibodies
Different kinds of biologics used to treat inflammatory bowel disease (including anti-integrin antibodies)
Primary outcome measures
- disease activity [Time frame: up to 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07181525 · 2025R0267-0001