1,095
Participants
Start Date
March 28, 2014
Primary Completion Date
April 16, 2020
Study Completion Date
April 16, 2020
Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.
Praxis fur Gastroenterologie am Bayerischen Platz, Berlin
Georgetown University Hospital, Washington D.C.
Gastroenterologie Eppendorfer Baum, Hamburg
Verein fur Wissenschaft und Fortbildung, Oldenburg
Asheville Gastroenterology Associates, PA, Asheville
Carle Foundation Hospital, Urbana
Louisiana Research Center, LLC, Shreveport
Scott and White Memorial Hospital, Temple
Duane Sheppard, GI Inc., Dartmouth
The Office of Dr. Bruce Musgrave, Kentville
Dr. Fashir Medical Inc., Sydney
Sudbury Endoscopy Center, Greater Sudbury
S. and T. Shulman Medicine Professional Corporation, North Bay
Oravec Medicine Professional Corporation, Oshawa
The Office of Dr. Pierre Laflamme, Saint-Charles-Borromée
Royal Berkshire NHS Foundation Trust, Reading
The Royal Bournemouth Hospital, Bournemouth
The Royal Hampshire County Hospital, Winchester
Oxford University Hospitals NHS Foundation - John Radcliffe Hospital, Headington
University Hospital Coventry, Coventry
New Cross Hospital - Royal Wolverhampton NHS Trust, Wolverhampton
Nottingham University Hospitals NHS Trust, Nottingham
Lead Sponsor
Alimentiv Inc.
OTHER