Induction Optimization With Stelara for Crohn's Disease

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
NYU Langone Health
Study ID
NCT04629196
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab — DRUG
    A second IV weight-based induction dose of Stelara at week 8
  • Ustekinumab — DRUG
    A standard 90mg subcutaneous dose of Stelara at week 8
  • Ustekinumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Feb 16, 2022
Status verified
Oct 2024
Primary completion
Jan 17, 2024
Completion
Jan 17, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IV Weight-Based Induction Dose
  • Active Comparator: Standard Subcutaenous Dose

Primary Outcome Measure

Crohn's Disease Activity Index (CDAI) Score [ Time Frame: Week 16 ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MarylandBaltimoreMaryland21201-
NYU Langone HealthNew YorkNew York10013-

Find similar trials in Baltimore, MD

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
University of Maryland· Baltimore, MDNYU Langone Health· New York, NY

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