Inflamatory Bowel DiseaseNCT07181525
Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease
An observational study of Inflamatory Bowel Disease, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflamatory Bowel Disease
- What is being tested?
- anti-cytokine antibodies and anti-integrin antibodies
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult inflammatory bowel disease patients in our hospital have no specific selection such as race, gender, or age.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Yun Dai, PhD, +86 (010)83575675, daiyun@bjmu.edu.cn
About this study
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
- Being tested
- anti-cytokine antibodies, anti-integrin antibodies
- Keywords
- inflammatory bowel disease, machine learning, biologics
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-cytokine antibodiesDrug
Different kinds of biologics used to treat inflammatory bowel disease (including anti-cytokine antibodies)
anti-integrin antibodiesDrug
Different kinds of biologics used to treat inflammatory bowel disease (including anti-integrin antibodies)
| Study group | Role | What they receive |
|---|---|---|
| CAT group | IBD patients treated with cytokine antagonists Receives: Drug: anti-cytokine antibodies | |
| IAT group | IBD patients treated with integrin antagonists Receives: Drug: anti-integrin antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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≥<.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Aug 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai Yun, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181525
- Sponsor's protocol ID
- 2025R0267-0001
- Status last verified
- Sep 2025
- First submitted
- 11 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07181525
- Acronym / sponsor ID
- 2025R0267-0001
- Conditions
- Inflamatory Bowel Disease
- Keywords
- inflammatory bowel disease, machine learning, biologics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAT group | – | Drug: anti-cytokine antibodiesIBD patients treated with cytokine antagonists |
| IAT group | – | Drug: anti-integrin antibodiesIBD patients treated with integrin antagonists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inflammatory bowel disease patients in our hospital have no specific selection such as race, gender, or age.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-cytokine antibodiesDifferent kinds of biologics used to treat inflammatory bowel disease (including anti-cytokine antibodies) | Drug | CAT group |
| anti-integrin antibodiesDifferent kinds of biologics used to treat inflammatory bowel disease (including anti-integrin antibodies) | Drug | IAT group |
Primary outcome
disease activity
Time frame: 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≥<.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflamatory Bowel Disease, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael Hong (+86 (010)83575675, doctoraphael@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease activity (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.