A Study on the Relationship of Interleukin-7 Receptor Gene Polymorphisms With the Risk of Crohn's Disease Onset and the Efficacy of Infliximab

November 24, 2025 updated by: Second Affiliated Hospital of Wenzhou Medical University
From January 2020 to May 2025, 303 CD patients and 514 normal controls were retrospectively collected from Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our study aimed to explore the the relationship of interleukin-7 receptor (IL-7R) gene polymorphisms with the risk of Crohn's disease (CD) onset, the clinicopathological features of CD and the efficacy of infliximab (IFX) therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From January 2020 to May 2025, 303 CD patients and 514 normal controls were retrospectively collected from Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our study aimed to explore the the relationship of interleukin-7 receptor (IL-7R) gene polymorphisms with the risk of Crohn's disease (CD) onset, the clinicopathological features of CD and the efficacy of infliximab (IFX) therapy. Multiple polymerase chain reaction ligase detection technology was used to detect the genotype of IL-7R (rs6897932, rs1494555, rs1494558). According to the Montreal CD classification criteria, patients were divided into different subgroups. The Crohn's Disease Activity Index (CDAI) is used to evaluate clinical activity, while the Simplified Crohn's Disease Endoscopic Score (SES-CD) is used to assess endoscopic activity.

Study Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

There was no statistically significant difference in the gender ratio, average age, and proportion of smokers between CD group and normal control group. All study subjects are from the Zhejiang Han population who are not related by blood

Description

Inclusion Criteria:

  • diagnosed CD based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

Exclusion Criteria:

  • rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
normal control
no biological agents treatment
CD patients
Some CD patients received intravenous injection of IFX (5mg/kg) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of IFX every 8 weeks to maintain treatment.
Biological: Infliximab
Intravenous injection of IFX (5mg/kg) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of IFX every 8 weeks to maintain treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotypes of IL-7R
Time Frame: Baseline
multiplex polymerase chain reaction-ligase detection reaction technique
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2025-01-228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn Disease (CD)

Clinical Trials on Infliximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe