Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01144156

Collaborator

Abbott (Industry)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: Treatment with Adalimumab	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy

Outcome Measures

Primary Outcome Measures

Complete mucosal healing [After 14 weeks of treatment]
Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy

Secondary Outcome Measures

Partial mucosal healing [After 14 weeks of treatment]
Reduction of at least 50% in the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) after treatment.
Correlation with clinical activity [After 14 weeks of treatment]
Statistical correlation between CECDAI reduction and reduction in clinical (CDAI, IBDQ) and laboratory (CRP, calprotectin etc.) indices of disease activity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.