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Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

NCT03464136 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2025-04-29

Study results available
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Summary

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

Conditions

  • Crohn Disease

Interventions

BIOLOGICAL

Placebo for Ustekinumab

Participants will receive placebo as SC injection to blind adalimumab.

BIOLOGICAL

Placebo for Adalimumab

Participants will receive placebo as IV infusion to blind ustekinumab.

BIOLOGICAL

Ustekinumab (6 mg/kg)

Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.

BIOLOGICAL

Ustekinumab (90 mg)

Participants will self-administer SC injection of ustekinumab 90 mg.

BIOLOGICAL

Adalimumab (40 mg)

Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.

Sponsors & Collaborators

  • Janssen Scientific Affairs, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2020-12-15
Completion
2021-05-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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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 NCT03464136 on ClinicalTrials.gov