Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: Ustekinumab
Intervention description: Participants will receive IV induction treatment with ustekinumab on a weight-tiered basis at a dose of approximately 6 milligram per kilogram (mg/kg) IV. At Week 8, all participants will receive a 90 mg SC injection of ustekinumab. During the routine care maintenance treatment period, in case of clinical worsening reported by the participant, consistent with disease flare in the investigator's judgment, clinical assessments of disease flare will be performed at the investigator's discretion.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled
      with early endoscopic assessment versus a clinically driven (routine care) approach in
      achieving endoscopic response.
    

Eligibility criteria:

        Inclusion Criteria:

        Main Study:

          -  Have active, moderate to severe, ileal and/or colonic Crohn's disease, demonstrated
             by: baseline CDAI score of greater than or equal to (>=) 220 and less than equal to
             (<=) 450, and endoscopy with evidence of active Crohn's disease (defined as simple
             endoscopic score for Crohn's disease [SES-CD] score >=3 excluding the contribution of
             the narrowing component score) obtained within the 5 week screening period. A prior
             endoscopy may be used only if obtained within 3 months prior to baseline (Week 0), in
             which case the prior endoscopy must be centrally read again and SES-CD calculated
             based on this second, centralized read-out

          -  Has had an inadequate response with, lost response to, was intolerant to, or had
             medical contraindications to either conventional therapy, or one previous biologic
             therapy approved for the treatment of Crohn's disease in the countries in which the
             study is conducted

          -  Are eligible according to tuberculosis (TB) infection screening criteria

          -  Must sign an informed consent form (ICF) or their legally acceptable representative if
             applicable must sign) indicating that he or she understands the purpose of, and
             procedures required for, the study and is willing to participate in the study.

        Sub-study:

          -  Be enrolled into the main study at a participating site

          -  Sign a separate ICF indicating that they understand the purpose of and procedures
             required for this sub-study and are willing to participate in the sub-study

          -  Satisfy all inclusion criteria and none of the exclusion criteria specified in the
             main study

        Exclusion Criteria:

        Main Study:

          -  Has complications of Crohn's disease such as symptomatic strictures or stenoses, short
             gut syndrome, or any other manifestation that might be anticipated to require surgery,
             could preclude the use of the Crohn's Disease Activity Index (CDAI) to assess response
             to therapy, or would possibly confound the ability to assess the effect of treatment
             with ustekinumab

          -  Currently has or is suspected to have an abscess. Recent cutaneous and perianal
             abscesses are not exclusionary if drained and adequately treated at least 3 weeks
             prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses,
             provided there is no anticipated need for any further surgery. Participants with
             active fistulas may be included if there is no anticipation of a need for surgery and
             there are currently no abscesses identified

          -  Has had any kind of bowel resection within 6 months prior to baseline

          -  Has a draining (i.e, functioning) stoma or ostomy

          -  Has received more than one previous biologic therapy approved for the treatment of
             Crohn's disease in the countries in which the study is conducted

        Sub-study:

          -  Obesity or other characteristics considered likely to preclude intestinal ultrasound
             (IUS) visualization of the affected bowel segment

          -  Normal bowel wall thickness (BWT) (that is, <=2.0 millimeter [mm] for the terminal
             ileum; <=3.0 mm for the colon) for all bowel segments at baseline (Week 0)