An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease
Public ClinicalTrials.gov record NCT02566889. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4, Multicenter, Open-label Study of Serum Infliximab Concentrations and Efficacy and Safety of Dose Escalation in Pediatric Patients With Inflammatory Bowel Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric participants with inflammatory bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above the currently approved dose \[5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)\] and the safety of that dose escalation.
Study identification
- NCT ID
- NCT02566889
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 53 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2016 (Actual)
- Primary completion
- Jul 2019 (Actual)
- Completion
- Jul 2019 (Actual)
- Last update posted
- Feb 4, 2025
2016 – 2019
United States locations
- U.S. sites
- 29
- U.S. states
- 21
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | San Francisco | California | — | — |
| Not listed | Hartford | Connecticut | — | — |
| Not listed | Wilmington | Delaware | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Peoria | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Shreveport | Louisiana | — | — |
| Not listed | Portland | Maine | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Waltham | Massachusetts | — | — |
| Not listed | Rochester | Minnesota | — | — |
| Not listed | Saint Paul | Minnesota | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | Mineola | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Stony Brook | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Fairfax | Virginia | — | — |
| Not listed | Madison | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02566889, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2025 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02566889 live on ClinicalTrials.gov.