At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Placebo for Ustekinumab, Placebo for Adalimumab, and 3 other interventions for Crohn Disease. Completed, enrolled 386 participants across 182 sites in 18 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive placebo as SC injection to blind adalimumab.
Participants will receive placebo as IV infusion to blind ustekinumab.
Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.
Participants will self-administer SC injection of ustekinumab 90 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.