NCT06739278

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

11 days

First QC Date

December 9, 2024

Last Update Submit

December 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • imaging remission rate of anal fistula

    Treatment week 0 to 32

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with perianal fistulizing Crohn's disease

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 18, 2024

Study Start

December 20, 2024

Primary Completion

December 31, 2024

Study Completion

January 31, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Locations