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)].
A Phase 4, Multicenter, Open-label Study of Serum Infliximab Concentrations and Efficacy and Safety of Dose Escalation in Pediatric Patients 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 (2 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 66 Weeks (including screening period). Participants' efficacy and safety outcomes will be monitored throughout the study.
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 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
You CAN'T join if...
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)
University Of Californiaaccepting new patients San Francisco, California, 94158, United States
Stanford/Lucille Packard Children's Hospitalnot yet accepting patients Stanford, California, 94304, United States
Children's Hospitalaccepting new patients Los Angeles, California, 90027, United States