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

Clalit Health Services

Status: Unknown

Conditions: Crohn's Disease

Treatments: Drug: Treatment with Adalimumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01144156

Gal002

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)