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

NCT ID: NCT07057856

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

866 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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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. Genotypes of IL-12RB1 were examined by multiplex polymerase chain reaction-ligase detection reaction technique. Unconditional logistic regression analysis was employed to analyze the distribution differences of IL-12RB1 gene polymorphisms between CD group and normal control group, as well as their influences on the clinicopathological characteristics and 8-week clinical response to UST treatment of CD patients.

Conditions

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Crohn's Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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CD patients

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

Ustekinumab (UST)

Intervention Type BIOLOGICAL

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

normal control

no biological agents treatment

No interventions assigned to this group

Interventions

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Ustekinumab (UST)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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SAHoWMU-CR2025-01-222

Identifier Type: -

Identifier Source: org_study_id

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