An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Infliximab
Intervention description: Participants in the dose escalation group will escalate dose from infliximab 5 mg/kg q8w to 10 mg/kg q8w at the time of loss response. Participants in the reference group will be maintained on infliximab 5 mg/kg q8w.
Intervention MeSH terms: Infliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Pediatric Inflammatory Bowel Disease; Infliximab; Pediatric Participants; Pediatric Ulcerative Colitis; Pediatric Crohn's Disease; Dose Escalation

Summary:

      The purpose of this study is to evaluate whether trough serum infliximab concentrations at
      the time of loss of clinical response will identify pediatric participants with inflammatory
      bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above
      the currently approved dose [5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)] and the
      safety of that dose escalation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a biopsy-confirmed diagnosis of Crohn's disease (CD) or ulcerative colitis
             (UC) prior to study entry

          -  Must meet concomitant medication stability criteria as specified in protocol

          -  Is considered eligible according to the tuberculosis (TB) Screening criteria specified
             in protocol

          -  Must have negative stool results for enteric pathogens. Stool studies must include a
             stool culture and Clostridium difficile toxin assay. These must have been performed
             during Screening or the current episode of disease exacerbation as long as the stool
             studies were performed within 4 months prior to the first administration of infliximab
             at Week 0

          -  Must have screening laboratory test results as specfied in the protocol

          -  Must be up to date with all immunizations in agreement with current local immunization
             guidelines for immunosuppressed participants prior to Screening

          -  Must not have discontinued infliximab therapy

        Exclusion Criteria:

          -  Must not require, or must not have required, within the 2 months prior to Screening,
             surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or
             intraabdominal or pancreatic abscess requiring surgical drainage, or other conditions
             possibly confounding the evaluation of benefit from infliximab treatment

          -  Must not have presence or history of colonic or small bowel obstruction within 6
             months prior to Screening, confirmed by objective radiographic or endoscopic evidence
             of a stricture with resulting obstruction (example, dilation of the colon or small
             bowel proximal to the stricture on barium radiograph or an inability to traverse the
             stricture at endoscopy)

          -  Must not have local manifestations of CD, such as fistulae, strictures, abscesses, or
             other disease complications for which surgery might be indicated. Enterocutaneuous
             fistulae for which surgery is not indicated, are allowed

          -  Must not have presence of a stoma

          -  Must not have documented short bowel syndrome (more than 100 centimeter in total of
             small bowel resected)