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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Rabin Medical Center Identifier:
First received: June 13, 2010
Last updated: June 14, 2010
Last verified: May 2010
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 Intervention
Crohn's Disease
Drug: Treatment with Adalimumab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy

Resource links provided by NLM:

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Complete mucosal healing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Estimated Enrollment: 30
Intervention Details:
    Drug: 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
    Other Name: Humira (Abbott Laboratories)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01144156

Rabin Medical Center - Beilinson Hospital
Petach Tikva, Israel, 4910
Sponsors and Collaborators
Rabin Medical Center
  More Information

Responsible Party: Dr Eyal Gal, Sherutei Briut Clalit Identifier: NCT01144156     History of Changes
Other Study ID Numbers: Gal002
Study First Received: June 13, 2010
Last Updated: June 14, 2010

Keywords provided by Rabin Medical Center:
Crohn's disease
Small bowel
Mucosal healing
Capsule endoscopy
Small bowel Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on April 28, 2017