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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • anti-cytokine antibodies

    Drug

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

  • anti-integrin antibodies

    Drug

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: CAT group1 intervention
Group B: IAT group1 intervention

Trial outcomes

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≥\<.

Time frame
up to 8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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