Clinical trial NCT06785493: The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Crohn's Disease
Official title: A Retrospective Analysis on the Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Patients With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBD (Inflammatory Bowel Disease)
Keywords: Ustekinumab
Individualized treatment
Clinical efficacy
Crohn&#39;s disease
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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).

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 .

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with moderate to severe Crohn's disease
2. Receiving treatment with ustekinumab

Exclusion Criteria:

1. Combined with other autoimmune diseases (such as systemic lupus erythematosus, Sjogren's syndrome, etc.), malignant tumors, or severe cardiovascular and cerebrovascular diseases
2. Merge active tuberculosis or severe infection
3. Liver and kidney dysfunction
4. Pregnancy or lactation period
5. Combination therapy with hormones, immunosuppressants, small molecule drugs, or other biological agents
6. Clinical data missing ≥ 30% or lost to follow-up during the follow-up period.

Primary outcomes:
measure: The endoscopic efficacy of ustekinumab treatment at week 36
timeFrame: at week 36
measure: The clinical efficacy of ustekinumab treatment at week 36
timeFrame: at week 36
Secondary outcomes:
measure: influencing factors
timeFrame: at week 36
measure: influencing factors
timeFrame: at week 36
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: