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NCT Number: NCT06739278

Individual Treatment of Ustekinumab in Perianal Fistulizing Crohn's Disease

This study intends to further explore the actual efficacy of ustekinumab in the individualized treatment of anal fistula Crohn's disease.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location contact

Luyan Fang

CONTACT

[email protected]

+86 13806552632

About this study

Participants in the study receive ustekinumab injections as part of routine medical care. The study just observes the efficacy retrospectively and does not interfere with treatment.

Who can participate

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

Inclusion criteria

  • Clinical diagnosis of Perianal Fistulizing Crohn's Disease
  • Receive ustekinumab therapy

Exclusion criteria

  • Ustekinumab combined with hormones, immunosuppressants, other biologics or small molecule drugs
  • Combined with other autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, Graves disease, etc.
  • Combined with serious infectious diseases, such as active tuberculosis, EBV infection, cytomegalovirus infection, etc.
  • Combined with malignant tumor
  • Clinical data missing ≥30% or no follow-up

Treatment and study plan

Primary outcomes

  1. imaging remission rate of anal fistula

    Time frame: Treatment week 0 to 32

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Analysis for the Efficacy of Individual Treatment of Perianal Fistulizing Crohn's Disease With Ustekinumab

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

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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