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Induction Optimization With Stelara for Crohn's Disease

NCT04629196 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-11-05

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • David Hudesman, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2024-01-17
Completion
2024-01-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT04629196 on ClinicalTrials.gov