Colitis, Ulcerative Clinical Trial
— ARCHOfficial title:
Multicenter Non-Therapeutic Study of Infliximab for Severe Refractory Colitis in Hospitalized Children
NCT number | NCT02799615 |
Other study ID # | 2014-0063; 2015-8753 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | November 2019 |
Verified date | July 2019 |
Source | Children's Hospital Medical Center, Cincinnati |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | November 2019 |
Est. primary completion date | February 11, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
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 | Connecticut Children's Hospital Medical Center | Hartford | Connecticut |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | Crohn's and Colitis Foundation |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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