Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy

Completed · Phase 4

Conditions studied: Crohn's Disease

In brief

Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.

Key facts

Study ID

NCT01698307

Run by

Alimentiv Inc.

People needed

1095

Starts

2014-03-28

Expected to finish

2020-04-16

Last updated by the study team

2021-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Asheville Gastroenterology Associates, PA — Asheville, North Carolina, United States
• Scott and White Memorial Hospital — Temple, Texas, United States
• Duane Sheppard, GI Inc. — Dartmouth, Nova Scotia, Canada
• The Office of Dr. Bruce Musgrave — Kentville, Nova Scotia, Canada
• Dr. Fashir Medical Inc. — Sydney, Nova Scotia, Canada
• Sudbury Endoscopy Center — Greater Sudbury, Ontario, Canada
• S. and T. Shulman Medicine Professional Corporation — North Bay, Ontario, Canada
• Oravec Medicine Professional Corporation — Oshawa, Ontario, Canada
• The Office of Dr. Pierre Laflamme — Saint-Charles-Borromée, Quebec, Canada
• Verein fur Wissenschaft und Fortbildung — Oldenburg, Lower Saxony, Germany
• Praxis fur Gastroenterologie am Bayerischen Platz — Berlin, Germany
• Gastroenterologie Eppendorfer Baum — Hamburg, Germany
• Royal Berkshire NHS Foundation Trust — Reading, Berkshire, United Kingdom
• The Royal Bournemouth Hospital — Bournemouth, Dorset, United Kingdom
• The Royal Hampshire County Hospital — Winchester, Hampshire, United Kingdom
• Oxford University Hospitals NHS Foundation - John Radcliffe Hospital — Headington, Oxford, United Kingdom
• University Hospital Coventry — Coventry, West Midlands, United Kingdom
• New Cross Hospital - Royal Wolverhampton NHS Trust — Wolverhampton, West Midlands, United Kingdom
• Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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