100
Participants
Start Date
April 30, 2012
Primary Completion Date
January 31, 2016
Study Completion Date
April 30, 2016
Adalimumab
Adalimumab will be administered sub-cutaneously to all patients entering the study with a loading dose of 80 mg followed by 40 mg at week 1 and 40 mg every other week. Patients who did not have small bowel lesions detected will be in the study and receive adalimumab until week 12. Patients who had small bowel lesions detected will be in the study and receive adalimumab until week 24.
Capsule endoscopy
All patients will undergo capsule endoscopy (EndoCapsule EC type 1; Olympus) to treatment initiation (adalimumab) in order to detect the presence of small bowel lesions suggestive of Crohn's disease. Twenty-four (24) weeks after treatment with adalimumab was initiated, patients for whom small bowel lesions were detected will undergo a second capsule endoscopy to evaluate changes in bowel inflammation.
Lynderm Research, Markham
Innovaderm Research Inc., Montreal
Dr Isabelle Delorme, Saint-Hyacinthe
Lead Sponsor
Collaborators (1)
Abbott
INDUSTRY
Innovaderm Research Inc.
OTHER