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

NCT07263477 | Completed FDA Drug

• 1 other identifier: SAHoWMU-CR2025-01-228
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease (CD)

Outcome Measures

Primary Outcomes (1)

• Genotypes of IL-7R

  multiplex polymerase chain reaction-ligase detection reaction technique

  Baseline

Study Arms (2)

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

Infliximab BIOLOGICAL

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.

CD patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Extract whole genome DNA from peripheral blood

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: January 1, 2020
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)