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

June 14, 2010 updated by: Rabin Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel, 4910
        • Rabin Medical Center - Beilinson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 14 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 14 weeks of 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.
After 14 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Collaborators

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 13, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 15, 2010

Last Update Submitted That Met QC Criteria

June 14, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gal002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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