NCT04629196

Induction Optimization With Stelara for Crohn's Disease

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Ustekinumab	A second IV weight-based induction dose of Stelara at week 8
DRUG	Ustekinumab	A standard 90mg subcutaneous dose of Stelara at week 8
DRUG	Ustekinumab	All patients will receive IV ustekinumab weight-based dose at 260mg (55kg or less), 390mg (more than 55kg to 85kg), or 520mg (more than 85kg) at time point 0

Timeline

• Start date: 2022-02-16
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2020-11-16
• Last updated: 2024-11-05
• Results posted: 2024-11-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study