A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 ["UNITI-1"] and CNTO1275CRD3002 ["UNITI-2"], compared to subcutaneously administered placebo.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease
Enrollment: 1315
Study Start Date: September 2011
Estimated Study Completion Date: November 2019
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Arms:
- Placebo Comparator: 001
- Experimental: 002
- Experimental: 003
- Experimental: 004
- Experimental: 005