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Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

NCT05705856 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-06-13

No results posted yet for this study

Summary

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.

Conditions

  • Crohn Disease

Interventions

DRUG

Ustekinumab

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Yan Chen, MD · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-15
Primary Completion
2023-12-31
Completion
2024-06-01
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705856 on ClinicalTrials.gov