A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Placebo (IP); Ustekinumab 1mg/kg (IP); Ustekinumab 3 mg/kg (IP); Ustekinumab 6 mg/kg (IP); Placebo IV - Responder - Placebo SC (MP); Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP); Ustekinumab IV - Responder - Placebo SC (MP); Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP); Ustekinumab IV - Nonresponder - Placebo SC (MP); Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)
Intervention description: Induction phase (Week 0-8) (IP) - Placebo IV group; Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group; Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group; Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group; Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16; Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16; Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16; Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16; Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Placebo SC at Week 8 and Week 16; Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 526.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interleukin-12; Inflammation; Research study; Ustekinumab; CNTO1275; Interleukin-23

Summary:

      A medical research study in adult patients who have moderate to severe Crohn's disease
      designed to determine whether or not treatment with an experimental drug called ustekinumab
      (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of
      Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration

          -  Must have received Remicade, adalimumab or Cimzia at a dose approved for the treatment
             of Crohn's disease

          -  Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of
             Crohn's disease

          -  Must be 18 years of age or older

          -  Must have active Crohn's disease according to the Crohn's Disease Activity Index (CDAI
             > =220 and < =450).

        Exclusion Criteria:

          -  Patients who have had any kind of bowel resection, diversions or placement of a stoma
             within 6 months

          -  Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the
             study or within 1 year after receiving study agent

          -  Patients who have received Remicade, Humira or Cimzia < =8 weeks before the first
             administration of study drug

          -  Patients with certain complications of Crohn's disease that would make it hard to
             assess response to study drug

          -  Patients with a history of or ongoing chronic or recurrent infectious disease.