Individual Treatment of Ustekinumab in Perianal Fistulizi... | NCT06739278

Studies
Individual Treatment of Ustekinumab in Perianal Fistulizing Crohn's Disease

NCT06739278

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Status

Not yet recruiting

Last Update Posted

Dec 18, 2024Actual

Enrollment

119Estimated

Phase

Not provided

Conditions

Crohn Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Jan 31, 2025Estimated

First Submitted Date

Dec 9, 2024

First Submission Date that Met QC Criteria

Dec 16, 2024

First Posted Date

Dec 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2024

Last Update Posted Date

Dec 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

119Estimated

Measure	Description	Time Frame
imaging remission rate of anal fistula		Treatment week 0 to 32

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

patients with perianal fistulizing Crohn's disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Jiang	Contact	+86-13676715543		1009419972@qq.com
Luyan Fang	Contact	+86 13806552632		239542008@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Wenzhou Medical University		Wenzhou	Zhejiang	325000	China

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided