An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease

This is a multicenter (when more than one hospital or medical school team work on a medical
research study), prospective (study following participants forward in time), open-label (all
people know the identity of the intervention) study of infliximab in pediatric participants
with inflammatory bowel disease. The study consists of 3 Phases: screening Phase (up to 4
weeks), open-label treatment Phase (56 weeks) and follow up safety Phase (8 weeks). The
duration of participation in the study for each participant is approximately up to 68 weeks
(including screening period). Participants' efficacy and safety outcomes will be monitored
throughout the study.

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)