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Anti-TNF Therapy for Refractory Colitis in Hospitalized Children

NCT02799615 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2020-04-10

No results posted yet for this study

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.

Conditions

  • Colitis, Ulcerative
  • Bowel Diseases, Inflammatory

Interventions

DRUG

Infliximab

No standard dosing regimen will be used and the dose of infliximab will be determined by the treating physician

Sponsors & Collaborators

  • Crohn's and Colitis Foundation

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Michael J Rosen, MD, MSCI · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-02-11
Completion
2019-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02799615 on ClinicalTrials.gov