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NCT01696396 · ClinicalTrials.gov registry record · Phase 2
Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 254
- Enrollment target
NCT01696396: Completed Phase 2 study, sponsored by Amgen.
NCT01696396 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 254 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696396, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 254 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI \< 150) after treatment for 8 weeks.
Primary Outcome
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150 at week 8. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease
Interventions
- DRUG Placebo
- DRUG Abrilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2012-12-04 |
| Est. Completion | 2018-04-10 |
| Phase | Phase 2 |
What the finished NCT01696396 record still lists
NCT01696396 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01696396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01696396 about?
NCT01696396 is a clinical study titled "Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease". The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI \< 150) after treatment for 8 weeks.
What is the current status of trial NCT01696396?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2012-12-04. Estimated completion is 2018-04-10.
What interventions are being tested in trial NCT01696396?
The interventions under investigation include: Placebo (DRUG), Abrilumab (DRUG).
Who is sponsoring clinical trial NCT01696396?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01696396's enrollment target sits among peer trials
254 219th of 2000 higher than 1,781 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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