Overview
Anti-TNF Therapy for Refractory Colitis in Hospitalized Children
Status:
Completed
Completed
Trial end date:
2019-11-01
2019-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Children's Hospital Medical Center, CincinnatiCollaborator:
Crohn's and Colitis FoundationTreatments:
Infliximab
Criteria
Inclusion Criteria:1. Age criteria: ≥ 4 or < 18 years of age
2. Diagnosis of UC or IBD-U by established criteria
3. Admitted to the hospital
4. Colitis extending beyond the rectosigmoid colon
5. PUCAI ≥ 65 at admission and ≥ 45 at first dose of infliximab
6. Treatment with infliximab considered by the treating physician
7. Anticipated follow-up ≥ 6 months from infliximab initiation
8. Permission/assent of parent/guardian and research participant.
Exclusion Criteria:
1. Diagnosis of Crohn's disease
2. Enteric infection with a bacterial pathogen (including clostridium difficile), per
review of medical records
3. Colon tissue positive for CMV by PCR, immunohistochemistry, or in situ hybridization,
per review of the medical records
4. Colitis currently extending only to the rectosigmoid colon (proctosigmoiditis)
5. Prior treatment with infliximab or other anti-TNF agent
6. Prior treatment with cyclosporine or tacrolimus
7. PUCAI < 45 the day of first infliximab infusion
8. Pregnancy, per review of medical records and verbal report
9. Other poorly controlled medical condition
10. Hepatic disease (AST or Alk Phos > 3 times the upper limit of normal) in the absence
of IBD associated liver disease
11. Renal disease (BUN and creatinine >1.5 times the upper limit of normal)