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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 is a Phase 4 study that was terminated before completion, run by Janssen Scientific Affairs. The registered enrollment target is 53 participants.
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.
Interventions
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02566889
The ClinicalTrials.gov registry entry for NCT02566889 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Scientific Affairs, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Infliximab is the first listed.
NCT02566889 reports 0 study locations.
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.
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