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NCT01190839 · ClinicalTrials.gov registry record · Phase 3
A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence
A Phase 3 study, sponsored by Janssen Biotech.
- Terminated
- Registry status
- Phase 3
- Development phase
- 297
- Enrollment target
NCT01190839: Clinical Trial Phase 3 study, sponsored by Janssen Biotech.
NCT01190839 is a Phase 3 study that was terminated before completion, run by Janssen Biotech. The registered enrollment target is 297 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190839, a Phase 3 study, was terminated before completion, sponsored by Janssen Biotech.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 297 participants
- Enrollment target
Study Summary
REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.
Primary Outcome
CR criteria:1) A \>=70-point increase from baseline in CDAI score \[in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities\];2)A CDAI score \>=200;3)Evidence of endoscopic recurrence \[ileal Rutgeerts score of \>=i2 at anastomotic site or its equivalent elsewhere in GI tract\] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of fol
Interventions
- DRUG Placebo
- BIOLOGICAL Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Why NCT01190839 stopped before completion
NCT01190839 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01190839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01190839 about?
NCT01190839 is a clinical study titled "A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence". REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo...
What is the current status of trial NCT01190839?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 297 participants. The study started on 2010-11. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01190839?
The interventions under investigation include: Placebo (DRUG), Infliximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01190839?
This trial is sponsored by Janssen Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01190839's enrollment target sits among peer trials
297 1163rd of 2000 higher than 837 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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