A Study of the Effectiveness and Safety of Infliximab for Pediatric Patients with Inflammatory Bowel Disease


About this study

The purpose of this study is to evaluate whether serum infliximab concentrations measured at the time of loss of clinical response will identify pediatric patients with inflammatory bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above the currently approved dose.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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)
  • Serpopositive for antibodieis to Hepatitis C. Virus
  • Any immunosuppressant biologic drug (approved or investigational ) within 4 weeks prior to first administration of infliximab or within 5 half lives of the investigational agent, whichever is longer, or is currently enrolled in an interventional study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

William Faubion, M.D.

Closed for enrollment

More information


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