Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy (REACT2)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Deep Remission, Complications
Eligibility Criteria
Inclusion Criteria:
- Documented diagnosis of CD
- Written informed consent must be obtained and documented.
- Willing to utilize study supply of adalimumab provided in syringe format, if indicated according to treatment algorithm.
Exclusion Criteria:
- Any conditions (e.g., history of alcohol or substance abuse) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures.
- Latex allergy or other conditions in which adalimumab syringes are contraindicated
- Currently participating, or planning to participate in a study involving investigational product within 24 months that may interfere with the patient's ability to comply with study procedures.
- Previously failed all classes of tumor necrosis factor (TNF) antagonists for the treatment of CD.
- Diagnosis of short bowel syndrome
Sites / Locations
- Georgetown University Hospital
- Carle Foundation Hospital
- Louisiana Research Center, LLC
- Asheville Gastroenterology Associates, PA
- Scott and White Memorial Hospital
- Duane Sheppard, GI Inc.
- The Office of Dr. Bruce Musgrave
- Dr. Fashir Medical Inc.
- S. and T. Shulman Medicine Professional Corporation
- Oravec Medicine Professional Corporation
- Sudbury Endoscopy Center
- The Office of Dr. Pierre Laflamme
- Verein fur Wissenschaft und Fortbildung
- Praxis fur Gastroenterologie am Bayerischen Platz
- Gastroenterologie Eppendorfer Baum
- Royal Berkshire NHS Foundation Trust
- The Royal Bournemouth Hospital
- The Royal Hampshire County Hospital
- Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
- University Hospital Coventry
- New Cross Hospital - Royal Wolverhampton NHS Trust
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Enhanced Treatment Algorithm
Conventional Step-care 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.
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).