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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144156
Recruitment Status : Unknown
Verified May 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2010
Last Update Posted : June 15, 2010
Information provided by:
Rabin Medical Center

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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)

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01144156

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Rabin Medical Center - Beilinson Hospital
Petach Tikva, Israel, 4910
Sponsors and Collaborators
Rabin Medical Center
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Responsible Party: Dr Eyal Gal, Sherutei Briut Clalit Identifier: NCT01144156    
Other Study ID Numbers: Gal002
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: May 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:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Antirheumatic Agents