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CompletedNCT07263477Updated Dec 4, 2025

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

An observational study in Crohn Disease (CD), sponsored by Second Affiliated Hospital of Wenzhou Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
900
Ages
18 Years to 70 Years
Sex
All
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Study summary

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.

Read the 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.

02

Conditions studied

  • Crohn Disease (CD)

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 900 is above the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
900 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • normal control

    no biological agents treatment

Interventions

  • BiologicalInfliximab

    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.

06

What researchers measure

Primary outcomes

  1. Genotypes of IL-7R

    multiplex polymerase chain reaction-ligase detection reaction technique

    Time frame: Baseline

07

Study locations

1 site
  • the Second Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07263477
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Dec 4, 2025
Start date
Jan 1, 2020
Primary completion
May 1, 2025
Completion
May 1, 2025
Last update
Dec 4, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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