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NCT02566889 · ClinicalTrials.gov registry record · Phase 4
An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease
A Phase 4 study, sponsored by Janssen Scientific Affairs.
- Terminated
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT02566889: Clinical Trial Phase 4 study, sponsored by Janssen Scientific Affairs.
NCT02566889 is a Phase 4 study that was terminated before completion, run by Janssen Scientific Affairs. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02566889, a Phase 4 study, was terminated before completion, sponsored by Janssen Scientific Affairs.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Clinical response was defined as Crohn's disease (CD) participants with decrease from baseline in PCDAI of greater than or equal to (\>=) 15 points with total score of less than or equal to (\<=) 30 points. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentat
Interventions
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-07 |
| Phase | Phase 4 |
Why NCT02566889 stopped before completion
NCT02566889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Infliximab is the first listed.
NCT02566889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02566889 about?
NCT02566889 is a clinical study titled "An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease". 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 d...
What is the current status of trial NCT02566889?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2016-04. Estimated completion is 2019-07.
What interventions are being tested in trial NCT02566889?
The interventions under investigation include: Infliximab (DRUG).
Who is sponsoring clinical trial NCT02566889?
This trial is sponsored by Janssen Scientific Affairs, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02566889's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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