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NCT Number: NCT06785493

The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in 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).

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Key information

Conditions

IBD (Inflammatory Bowel Disease) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with moderate to severe Crohn's disease
  • Receiving treatment with ustekinumab

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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) .

  2. 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).

Secondary outcomes

  1. influencing factors

    Time frame: at week 36

    At week 36, analyze the influencing factors of clinical remission rate(HBI≤ 4 points) .

  2. influencing factors

    Time frame: at week 36

    At week 36, analyze the influencing factors of endoscopic remission rate(SES-CD ≤ 2 points, or no ulcers).

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

A Retrospective Analysis on the Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Patients With Crohn's Disease

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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