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NCT02096861 · ClinicalTrials.gov registry record · Phase 3
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Celltrion.
- Completed
- Registry status
- Phase 3
- Development phase
- 220
- Enrollment target
- 1
- Study location
NCT02096861: Completed Phase 3 study of Crohn's Disease, sponsored by Celltrion.
NCT02096861 is a Phase 3 study of Crohn's Disease that has completed, run by Celltrion. The registered enrollment target is 220 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02096861, a Phase 3 study of Crohn's Disease, has completed, sponsored by Celltrion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 220 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
Primary Outcome
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.
Conditions Studied
Interventions
- BIOLOGICAL CT-P13
- BIOLOGICAL Remicade
Study Locations (1)
Tennessee
- Nashville Medical Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2014-09-19 |
| Est. Completion | 2017-02-15 |
| Phase | Phase 3 |
What the finished NCT02096861 record still lists
NCT02096861 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which CT-P13 is the first listed.
NCT02096861 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT02096861 about?
NCT02096861 is a clinical study titled "Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease". This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
What is the current status of trial NCT02096861?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2014-09-19. Estimated completion is 2017-02-15.
What conditions does trial NCT02096861 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT02096861?
The interventions under investigation include: CT-P13 (BIOLOGICAL), Remicade (BIOLOGICAL).
Who is sponsoring clinical trial NCT02096861?
This trial is sponsored by Celltrion, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02096861 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02096861's enrollment target sits among peer trials
220 50th of 105 higher than 56 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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