Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05705856
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    Patients will receive an intravenous induction (adjusted 6 mg/kg dose) followed by subcutaneous 90 mg every 12 or 8 weeks, and will receive dose escalation when response is not effective enough.

Study Details

The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.

Key Dates

Start date
Feb 15, 2023
Status verified
Jan 2023
Primary completion
Dec 31, 2023
Completion
Jun 1, 2024

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: intravenous maintenance at early stage
    Participants who have evidence of high activity clinically, biochemically or endoscopically : HBI ≥8, inflammatory markers significantly increased (CRP \> 5mg/L, fecal calprotectin\> 200mg/g), SES-CD≥ 7, will get multiple intravenous injections of Ustekinumab maintenance after induction.
  • Arm: intravenous escalation when poor response
    Participants who experience a loss of response or poor response to 90 mg Ustekinumab standard therapy will receive Ustekinumab intravenously at regular interval or at shorten interval.

Primary Outcome Measure

Percentage of participants with steroid-free clinical remission at Week 24 [ Time Frame: Week24 ]

Central Contacts

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