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Summary

for people ages 6–16 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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)].

Official Title

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

Details

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.

Keywords

Inflammatory Bowel Diseases Pediatric Inflammatory Bowel Disease Infliximab Pediatric Participants Pediatric Ulcerative Colitis Pediatric Crohn's Disease Dose Escalation

Eligibility

You can join if…

Open to people ages 6–16

  • 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)

Locations

  • Stanford/Lucille Packard Children's Hospital not yet accepting patients
    Stanford, California, 94304, United States
  • Children's Hospital currently not accepting new patients, but might later
    Los Angeles, California, 90027, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Scientific Affairs, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT02566889
Phase
Phase 4
Lead Scientist
Melvin Heyman
Study Type
Interventional
Last Updated
August 1, 2017
I’m interested in this study!