NCT03464136.

Trial name or title	Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year (SEAVUE)
Methods	Randomized, blinded, active‐controlled study
Participants	Inclusion criteria: moderate to severe Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, has not previously received an approved biologic for Crohn's disease Exclusion criteria: has complications of Crohn's disease that are likely to require surgery
Interventions	Group 1: Ustekinumab. Participants will receive IV infusion of ustekinumab (6 mg/kg) and 4 SC injections of placebo for adalimumab at week 0, followed by 2 SC injections of placebo at week 2. From week 4 to week 56, participants will self‐administer 1 SC injection of ustekinumab 90 mg every 8 weeks starting at week 8 and placebo adalimumab at 2 week dosing intervals. Group 2: Adalimumab. Participants will receive IV infusion of placebo for ustekinumab and 4 SC injections of adalimumab (each 40 mg, total dose 160 mg) at week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at week 2. From week 4 to week 56, participants will self‐administer 1 SC injection of adalimumab 40 mg every 2 weeks.
Outcomes	Primary outcome: Clinical remission at week 52 Secondary outcomes: Corticosteroid‐free remission at week 52 Clinical response at week 52 Endoscopic remission at week 52 Clinical remission at week 16 Clinical response through week 52
Starting date	29 March 2018
Contact information	Janssen Scientific Affairs, LLC Telephone: 844‐434‐4210; email: JNJ.CT@sylogent.com
Notes

IV: intravenous; SC:subcutaneous