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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 because the information has not been verified recently.
Verified May 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01144156
First received: June 13, 2010
Last updated: June 14, 2010
Last verified: May 2010
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
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:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Complete mucosal healing [ Time Frame: After 14 weeks of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144156

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

Publications:

Responsible Party: Dr Eyal Gal, Sherutei Briut Clalit
ClinicalTrials.gov Identifier: NCT01144156     History of Changes
Other Study ID Numbers: Gal002
Study First Received: June 13, 2010
Last Updated: June 14, 2010
Health Authority: Israel: Israeli Ministry of Health.

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

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013