Study Complete
Sponsor ID
20110232

Abrilumab (AMG 181) in Adults with Moderate to Severe Crohn's Disease

Sponsor ID
20110232
Clinicaltrials.gov ID
NCT01696396
EUCTIS ID
N/A
EudraCT ID
2012-000529-31

Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 181
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
254
Additional Study Details

Protocol Summary

Primary Outcome Measures

CDAI remission

Timeframe: week 8

Secondary Outcome Measures

CDAI response

Timeframe: week 8 or week 12

Sustained CDAI remission

Timeframe: week 8 & week 24 and at week 12 & week 24

CDAI change

Timeframe: week 8 & week 12

CDAI remission

Timeframe: week 12

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Hospital
New York, New York, United States, 10029
Status
Recruiting
Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
Location
Research Site
Arlington Heights, IL, United States, 60005
Status
Completed
Location
Research Site
Birmingham, AL, United States, 35216
Status
Recruiting
Location
Research Site
Bonheiden, Belgium, 2820
Status
Recruiting
Location
Research Site
Brussels, Belgium, 1200
Status
Recruiting
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