A Study of the Effectiveness and Safety of Infliximab for Pediatric Patients with Inflammatory Bowel Disease
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006401
NCT ID: NCT02566889
Sponsor Protocol Number: C0168IBD4020
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
Publications
Publications are currently not available