Anti-TNF Therapy for Refractory Colitis in Hospitalized Children
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Multicenter Non-Therapeutic Study of Infliximab for Severe Refractory Colitis in Hospitalized Children
1 other identifier
observational
38
2 countries
7
Brief Summary
This multicenter study is being conducted to determine whether infliximab exposure after an initial infusion is predictive of early clinical response in hospitalized pediatric patients with severe steroid-refractory UC or IBD-U. This pilot and feasibility study will establish the infrastructure, demonstrate feasibility, and collect preliminary data to support the full study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2016
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 9, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedApril 10, 2020
July 1, 2019
2.8 years
June 9, 2016
April 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be the relationship between IFX exposure (area under the curve of the PK model) and Day 7 clinical response defined as Pediatric Ulcerative Colitis Activity Index (PUCAI) <35.
IFX exposure and Day 7 PUCAI
7 days
Interventions
No standard dosing regimen will be used and the dose of infliximab will be determined by the treating physician
Eligibility Criteria
Research participants age 4 to 17 will be eligible for this study. Our target is a minimum of 36 evaluable research participants (to a maximum of 40) across up to 6 participating centers.
You may qualify if:
- Age criteria: ≥ 4 or \< 18 years of age
- Diagnosis of UC or IBD-U by established criteria
- Admitted to the hospital
- Colitis extending beyond the rectosigmoid colon
- PUCAI ≥ 65 at admission and ≥ 45 at first dose of infliximab
- Treatment with infliximab considered by the treating physician
- Anticipated follow-up ≥ 6 months from infliximab initiation
- Permission/assent of parent/guardian and research participant.
You may not qualify if:
- Diagnosis of Crohn's disease
- Enteric infection with a bacterial pathogen (including clostridium difficile), per review of medical records
- Colon tissue positive for CMV by PCR, immunohistochemistry, or in situ hybridization, per review of the medical records
- Colitis currently extending only to the rectosigmoid colon (proctosigmoiditis)
- Prior treatment with infliximab or other anti-TNF agent
- Prior treatment with cyclosporine or tacrolimus
- PUCAI \< 45 the day of first infliximab infusion
- Pregnancy, per review of medical records and verbal report
- Other poorly controlled medical condition
- Hepatic disease (AST or Alk Phos \> 3 times the upper limit of normal) in the absence of IBD associated liver disease
- Renal disease (BUN and creatinine \>1.5 times the upper limit of normal)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Connecticut Children's Hospital Medical Center
Hartford, Connecticut, 06016, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
Related Publications (1)
Whaley KG, Xiong Y, Karns R, Hyams JS, Kugathasan S, Boyle BM, Walters TD, Kelsen J, LeLeiko N, Shapiro J, Waddell A, Fox S, Bezold R, Bruns S, Widing R, Haberman Y, Collins MH, Mizuno T, Minar P, D'Haens GR, Denson LA, Vinks AA, Rosen MJ. Multicenter Cohort Study of Infliximab Pharmacokinetics and Therapy Response in Pediatric Acute Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 May;21(5):1338-1347. doi: 10.1016/j.cgh.2022.08.016. Epub 2022 Aug 27.
PMID: 36031093DERIVED
Biospecimen
Blood, blood DNA, serum, plasma, colon endoscopic biopsy tissue (RNA/DNA/Formalin-fixed), stool (DNA and supernatant)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Rosen, MD, MSCI
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2016
First Posted
June 15, 2016
Study Start
May 1, 2016
Primary Completion
February 11, 2019
Study Completion
November 1, 2019
Last Updated
April 10, 2020
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share