Re-induction with Ustekinumab in Patients with Moderately to Severely Active Crohn's
- Ustekinumab (STELARA) re-induction for patients with a loss of response being on a current dose of ustekinumab SC Q8W 90mg maintenance treatment. Need to have had at least 2 doses of SC 90mg of ustekinumab prior to enrollment.
- Randomized 1:1 ratio to 1 of 2 intervention groups to receive either IV ustekinumab ~6 mg/kg and SC placebo or IV placebo and SC ustekinumab 90 mg in a blinded manner.
- 16 weeks of treatment period followed by 2 follow up visits on WK24 and 36 or at 20weeks after last dose.
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