Crohn DiseaseNCT06739278
Individual Treatment of Ustekinumab in Perianal Fistulizing Crohn's Disease
An observational study of Crohn Disease, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This study intends to further explore the actual efficacy of ustekinumab in the individualized treatment of anal fistula Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: patients with perianal fistulizing Crohn's disease
Who may be able to join
- Clinical diagnosis of Perianal Fistulizing Crohn's Disease
- Receive ustekinumab therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Luyan Fang, +86 13806552632, 239542008@qq.com
About this study
Official title: Analysis for the Efficacy of Individual Treatment of Perianal Fistulizing Crohn's Disease With Ustekinumab
This study intends to further explore the actual efficacy of ustekinumab in the individualized treatment of anal fistula Crohn's disease.
Read the 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.
- Conditions
- Crohn Disease
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
imaging remission rate of anal fistula
Measured: Treatment week 0 to 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739278
- Sponsor's protocol ID
- SAHoWMU-CR2024-01-222
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis for the Efficacy of Individual Treatment of Perianal Fistulizing Crohn's Disease With Ustekinumab
- ClinicalTrials.gov ID
- NCT06739278
- Acronym / sponsor ID
- SAHoWMU-CR2024-01-222
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with perianal fistulizing Crohn's disease
Key inclusion criteria (2 listed)
- Clinical diagnosis of Perianal Fistulizing Crohn's Disease
- Receive ustekinumab therapy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
imaging remission rate of anal fistula
Time frame: Treatment week 0 to 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Jiang (+86-13676715543, 1009419972@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
imaging remission rate of anal fistula (time frame: Treatment week 0 to 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.