Status:
UNKNOWN
Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
Abbott
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study hypothesis is that adalimumab induces mucosal healing in the small bowel and that mucosal healing correlates with disease activity. 30 Patients with isolated active small bowel Crohn's disea...
Eligibility Criteria
Inclusion
- Isolated small bowel Crohn's disease.
- Age ≥18.
- Active disease (CDAI≥220).
Exclusion
- Known fixed stricture in the small intestine.
- Former small bowel obstruction or obstructive symptoms.
- Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
- Colonic disease (except ileocecal valve area).
- Anti-TNF treatment in the last 3 months.
- Sensitivity or lack of response to previous adalimumab treatment.
- Current gastrointestinal infection.
- History of malignant disease (except BCC of skin).
- Congestive heart failure, severe renal or hepatic dysfunction.
- Patients suffering from tuberculosis, hepatitis B or C.
- Pregnancy or unwillingness to use contraception during study period.
- Dysphagia or swallowing disorders
- Gastroparesis or severe gastrointestinal motility dysfunction.
- Patients with cardiac pacemaker or implanted cardioverter devices.
- Unable to sign informed consent.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01144156
Last Update
June 15 2010
Active Locations (1)
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1
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel, 4910