Clinical trial NCT01144156: Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
Official title: Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's disease
Small bowel
Mucosal healing
Capsule endoscopy
Adalimumab
Small bowel Crohn's disease
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2010-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 disease which are candidates to receive anti-TNF treatment will be included in the study. All patients will undergo patency capsule examination and capsule endoscopy afterwards. Small bowel endoscopic disease severity will be assessed by the capsule endoscopy Crohn's disease activity index (CECDAI). The patients will receive Adalimumab (Humira)injections (160mg,80mg and 40mg every 2 weeks ) for 12 weeks. on week 14 a second capsule endoscopy will be performed and CECDAI calculated again. The patients clinical condition, CDAI,IBDQ and laboratory results including CRP, CBC and fecal calprotectin will be assessed on weeks o, 7 and 14 and results will be compared with the endoscopic score.


Eligibility criteria: Inclusion Criteria:

1. Isolated small bowel Crohn's disease.
2. Age ≥18.
3. Active disease (CDAI≥220).

Exclusion Criteria:

1. Known fixed stricture in the small intestine.
2. Former small bowel obstruction or obstructive symptoms.
3. Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
4. Colonic disease (except ileocecal valve area).
5. Anti-TNF treatment in the last 3 months.
6. Sensitivity or lack of response to previous adalimumab treatment.
7. Current gastrointestinal infection.
8. History of malignant disease (except BCC of skin).
9. Congestive heart failure, severe renal or hepatic dysfunction.
10. Patients suffering from tuberculosis, hepatitis B or C.
11. Pregnancy or unwillingness to use contraception during study period.
12. Dysphagia or swallowing disorders
13. Gastroparesis or severe gastrointestinal motility dysfunction.
14. Patients with cardiac pacemaker or implanted cardioverter devices.
15. Unable to sign informed consent.

Primary outcomes:
measure: Complete mucosal healing
timeFrame: After 14 weeks of treatment
Secondary outcomes:
measure: Partial mucosal healing
timeFrame: After 14 weeks of treatment
measure: Correlation with clinical activity
timeFrame: After 14 weeks of treatment
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
Study officials:
References:
citation: Gal E, Geller A, Fraser G, Levi Z, Niv Y. Assessment and validation of the new capsule endoscopy Crohn's disease activity index (CECDAI). Dig Dis Sci. 2008 Jul;53(7):1933-7. doi: 10.1007/s10620-007-0084-y. Epub 2007 Nov 22.