A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade)
      in children with moderately to severely active ulcerative colitis.
    

Detailed description: 
      Ulcerative Colitis (UC) is a disorder involving the lining of the colon. A substance called
      "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is thought to play an
      important role in the development of ulcerative colitis by causing some of the damage that is
      seen in the colon. "Antibodies" are normally made in the body and help fight off infection.
      Infliximab is an antibody that is made in a scientific laboratory, using parts of both mouse
      and human antibodies. It has been designed to attach to TNF, making it difficult for TNF to
      do any damage. This study will be done at centers in North America and Europe. Each child
      will first have a clinic visit (screening visit) to have some tests done to make sure the
      child is the type of patient who should be in this study. At the 2nd visit (week 0), the
      child will have the first treatment with infliximab. All children in the study will receive 5
      mg/kg infliximab 3 times (at weeks 0, 2 and 6) over the first 6 weeks of the study. If the
      child's symptoms do not improve by the 8th week, the child will receive no further infusions,
      but will return for safety evaluations. If the child's symptoms do improve, the child will be
      randomly assigned (like the flip of a coin) to either 5 mg/kg infliximab every 8 weeks
      through week 46 or 5 mg/kg infliximab every 12 weeks through week 42. If the child gets worse
      after being randomly assigned, the amount of infliximab may be increased or the infliximab
      may be given more frequently. A final infusion will be given at either week 42 or week 46.
      There will be a safety evaluation at week 54 and a visit at week 62 to get a blood sample.
      Patients will receive 5 mg/kg of infliximab at weeks 0, 2 and 6 and then 5mg/kg infliximab
      either every 8 weeks or 12 weeks until weeks 42 or 46. Infliximab is given as an intravenous
      infusion over 2 hours.
    

Intervention name(s): infliximab; infliximab; infliximab; infliximab
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42; infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46; infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42; infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative colitis; inflammatory bowel disease; children