Anti-TNF Therapy for Refractory Colitis in Hospitalized Children

Completed

Conditions studied: Colitis, Ulcerative, Bowel Diseases, Inflammatory

In brief

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.

Key facts

Study ID

NCT02799615

Run by

Children's Hospital Medical Center, Cincinnati

People needed

38

Starts

2016-05-01

Expected to finish

2019-11-01

Last updated by the study team

2020-04-10

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Connecticut Children's Hospital Medical Center — Hartford, Connecticut, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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