IBD (Inflammatory Bowel Disease)NCT06785493
The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Crohn's Disease
An observational study of IBD (Inflammatory Bowel Disease), run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab (UST) in patients with Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBD (Inflammatory Bowel Disease)
- What is being tested?
- Optimized Treatment (OPT)
- Type of treatment
- Injection or infusion
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).
Who may be able to join
- Diagnosed with moderate to severe Crohn's disease
- Receiving treatment with ustekinumab
Who cannot join
- Combined with other autoimmune diseases (such as systemic lupus erythematosus, Sjogren's syndrome, etc.), malignant tumors, or severe cardiovascular and cerebrovascular diseases
- Merge active tuberculosis or severe infection
- Liver and kidney dysfunction
- Pregnancy or lactation period
- Combination therapy with hormones, immunosuppressants, small molecule drugs, or other biological agents
- Clinical data missing ≥ 30% or lost to follow-up during the follow-up period.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
Official title: A Retrospective Analysis on the Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Patients With Crohn's Disease
The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab (UST) in patients with Crohn's disease (CD).
Read the detailed description
Interleukin (IL-12) and interleukin (IL-23) co-contain the P40 subunit, and ustekinumab (UST) is a fully humanized IgG1 monoclonal antibody that targets the P40 subunit. The conventional regimen of UST in the treatment of Crohn's disease is that after the first sufficient dose (6 mg/kg) of intravenous infusion, 90 mg UST is injected subcutaneously at the 8th week according to the patient's response, and maintenance therapy is given every 8 or 12 weeks. However, data from real-world studies suggest that the clinical efficacy of treating CD with the conventional UST regimen is less than ideal.Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab in patients with Crohn's disease .
- Conditions
- IBD (Inflammatory Bowel Disease)
- Being tested
- Optimized Treatment (OPT)
- Keywords
- Ustekinumab, Individualized treatment, Clinical efficacy, Crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized Treatment (OPT)Drug
After the first sufficient intravenous infusion of UST (6 mg/kg), the patient's response was assessed based on PRO2 at week 8, and an individualized treatment plan was developed. At week 8, the patients with incomplete response of PRO2 (a decline of PRO2 was less than 50% from baseline or still in moderate to severe active phase of PRO2) were given one or more UST intravenous re-induction (6 mg/kg) every 4 or 6 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
The endoscopic efficacy of ustekinumab treatment at week 36
Simplified Crohn's Disease Endoscopic Score (SES-CD) was employed to evaluate the degree of intestinal inflammation of CD patients.Intestinal inflammation was assessed as mild (3-6 points) , moderate (7-15 points) , and severe (≥16 points) .
Measured: at week 36
The clinical efficacy of ustekinumab treatment at week 36
Harvey-Bradshaw Index (HBI) was applied to assess the clinical activity of CD patients.HBI is divided into mild (5-7 points), moderate (8-16 points), and severe (≥ 17 points).
Measured: at week 36
Secondary outcomes (2)
influencing factors
At week 36, analyze the influencing factors of clinical remission rate(HBI≤ 4 points) .
Measured: at week 36
influencing factors
At week 36, analyze the influencing factors of endoscopic remission rate(SES-CD ≤ 2 points, or no ulcers).
Measured: at week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start1 Jul 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies 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
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785493
- Sponsor's protocol ID
- SAHoWMU-CR2025-01-201
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis on the Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT06785493
- Acronym / sponsor ID
- SAHoWMU-CR2025-01-201
- Conditions
- IBD (Inflammatory Bowel Disease)
- Keywords
- Ustekinumab, Individualized treatment, Clinical efficacy, Crohn's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Jan 2025 (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.
The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab (UST) in patients with Crohn's disease (CD).
Detailed description
Interleukin (IL-12) and interleukin (IL-23) co-contain the P40 subunit, and ustekinumab (UST) is a fully humanized IgG1 monoclonal antibody that targets the P40 subunit. The conventional regimen of UST in the treatment of Crohn's disease is that after the first sufficient dose (6 mg/kg) of intravenous infusion, 90 mg UST is injected subcutaneously at the 8th week according to the patient's response, and maintenance therapy is given every 8 or 12 weeks. However, data from real-world studies suggest that the clinical efficacy of treating CD with the conventional UST regimen is less than ideal.Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab in patients with Crohn's disease .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).
Key inclusion criteria (2 listed)
- Diagnosed with moderate to severe Crohn's disease
- Receiving treatment with ustekinumab
Key exclusion criteria (6 listed)
- Combined with other autoimmune diseases (such as systemic lupus erythematosus, Sjogren's syndrome, etc.), malignant tumors, or severe cardiovascular and cerebrovascular diseases
- Merge active tuberculosis or severe infection
- Liver and kidney dysfunction
- Pregnancy or lactation period
- Combination therapy with hormones, immunosuppressants, small molecule drugs, or other biological agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized Treatment (OPT)After the first sufficient intravenous infusion of UST (6 mg/kg), the patient's response was assessed based on PRO2 at week 8, and an individualized treatment plan was developed. At week 8, the patients with incomplete response of PRO2 (a decline of PRO2 was less than 50% from baseline or still in moderate to severe active phase of PRO2) were given one or more UST intravenous re-induction (6 mg/kg) every 4 or 6 weeks. | Drug | – |
Primary outcome
The endoscopic efficacy of ustekinumab treatment at week 36
Time frame: at week 36
Simplified Crohn's Disease Endoscopic Score (SES-CD) was employed to evaluate the degree of intestinal inflammation of CD patients.Intestinal inflammation was assessed as mild (3-6 points) , moderate (7-15 points) , and severe (≥16 points) .
The clinical efficacy of ustekinumab treatment at week 36
Time frame: at week 36
Harvey-Bradshaw Index (HBI) was applied to assess the clinical activity of CD patients.HBI is divided into mild (5-7 points), moderate (8-16 points), and severe (≥ 17 points).
2 secondary outcomes
influencing factors
Time frame: at week 36
influencing factors
Time frame: at week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 IBD (Inflammatory Bowel 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 6 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: finished, as of the sponsor's last update on 21 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endoscopic efficacy of ustekinumab treatment at week 36 (time frame: at week 36). The study lists 2 primary outcomes in all. 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 21 Jan 2025.