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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Abbott
Information provided by:
Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE June 13, 2010
First Posted Date  ICMJE June 15, 2010
Last Update Posted Date June 15, 2010
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
Official Title  ICMJE Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE 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)
Study Arms  ICMJE Not Provided
Publications * Gal E, Geller A, Fraser G, Levi Z, Niv Y. Assessment and validation of the new capsule endoscopy Crohn's disease activity index (CECDAI). Dig Dis Sci. 2008 Jul;53(7):1933-7. Epub 2007 Nov 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01144156
Other Study ID Numbers  ICMJE Gal002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Eyal Gal, Sherutei Briut Clalit
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Abbott
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP