An Analysis of the Relationship Between the Genetic Polymorphisms of Interleukin 12 Receptor Subunit Beta 1 and Crohn's Disease in Chinese Patients

NCT07057856 | Completed FDA Drug

• 1 other identifier: SAHoWMU-CR2025-01-222
• Study Type: observational
• Target: 866
• Locations: 1 country
• Sites: 1

Brief Summary

From January 2018 to May 2025, diagnosed CD patients and gender- and age-matched normal controls were collected from Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Our study aimed to explore the associations of interleukin 12 receptor subunit beta 1 (IL-12RB1) gene polymorphisms with the risk and clinicopathological characteristics of Crohn's disease (CD), and to analyze the effects of IL-12RB1 gene variations on the clinical response of ustekinumab (UST) treatment in CD patients at week 8.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Genotypes of IL-12RB1

  multiplex polymerase chain reaction-ligase detection reaction technique

  Baseline

Study Arms (2)

CD patients

Some CD patients received UST treatment and the first sufficient dose of UST (6mg/kg) was administered intravenously.

Biological: Ustekinumab (UST)

normal control

no biological agents treatment

Interventions

Ustekinumab (UST) BIOLOGICAL

The first sufficient dose of UST (6mg/kg) was administered intravenously at weeks 0

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, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Extract whole genome DNA from peripheral blood

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; 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: June 30, 2025
• First Posted: July 10, 2025
• Study Start: January 1, 2018
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)