NCT05705856

Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study evaluates the efficacy and safety of intravenous administration at regular intervals of Ustekinumab. It consists of escalation treatment period (Week 0 to 52); and safety follow up visit (24 weeks after last dose). Study assessments will include Harvey-Bradshaw index (HBI), Physician Global Assessment Score (PGA), laboratory evaluations, endoscopic evaluation, review of concomitant medications and adverse events (AEs).

Conditions

• Crohn Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-12-31
• Completion: 2024-06-01
• First posted: 2023-01-31
• Last updated: 2023-06-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study