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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Treatment with Adalimumab

All patients will receive SC adalimumab 160 mg at week 0, 80 mg at week 2 and 40 mg from week 4 every 2 weeks up to 12 weeks

Intervention Type DRUG

Other Intervention Names

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Humira (Abbott Laboratories)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No