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OpenTrials
Completed

NCT Number: NCT07057856

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ustekinumab (UST)

Biological

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

Primary outcomes

  1. Genotypes of IL-12RB1

    Time frame: Baseline

    multiplex polymerase chain reaction-ligase detection reaction technique

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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