Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
Primary Purpose
Crohn's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Treatment with Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Small bowel, Mucosal healing, Capsule endoscopy, Adalimumab, Small bowel Crohn's disease
Eligibility Criteria
Inclusion Criteria:
- Isolated small bowel Crohn's disease.
- Age ≥18.
- Active disease (CDAI≥220).
Exclusion Criteria:
- Known fixed stricture in the small intestine.
- Former small bowel obstruction or obstructive symptoms.
- Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
- Colonic disease (except ileocecal valve area).
- Anti-TNF treatment in the last 3 months.
- Sensitivity or lack of response to previous adalimumab treatment.
- Current gastrointestinal infection.
- History of malignant disease (except BCC of skin).
- Congestive heart failure, severe renal or hepatic dysfunction.
- Patients suffering from tuberculosis, hepatitis B or C.
- Pregnancy or unwillingness to use contraception during study period.
- Dysphagia or swallowing disorders
- Gastroparesis or severe gastrointestinal motility dysfunction.
- Patients with cardiac pacemaker or implanted cardioverter devices.
- Unable to sign informed consent.
Sites / Locations
- Rabin Medical Center - Beilinson Hospital
Outcomes
Primary Outcome Measures
Complete mucosal healing
Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy
Secondary Outcome Measures
Partial mucosal healing
Reduction of at least 50% in the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) after treatment.
Correlation with clinical activity
Statistical correlation between CECDAI reduction and reduction in clinical (CDAI, IBDQ) and laboratory (CRP, calprotectin etc.) indices of disease activity.
Full Information
NCT ID
NCT01144156
First Posted
June 13, 2010
Last Updated
June 14, 2010
Sponsor
Rabin Medical Center
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT01144156
Brief Title
Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
Official Title
Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, Small bowel, Mucosal healing, Capsule endoscopy, Adalimumab, Small bowel Crohn's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Treatment with Adalimumab
Other Intervention Name(s)
Humira (Abbott Laboratories)
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete mucosal healing
Description
Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy
Time Frame
After 14 weeks of treatment
Secondary Outcome Measure Information:
Title
Partial mucosal healing
Description
Reduction of at least 50% in the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) after treatment.
Time Frame
After 14 weeks of treatment
Title
Correlation with clinical activity
Description
Statistical correlation between CECDAI reduction and reduction in clinical (CDAI, IBDQ) and laboratory (CRP, calprotectin etc.) indices of disease activity.
Time Frame
After 14 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Isolated small bowel Crohn's disease.
Age ≥18.
Active disease (CDAI≥220).
Exclusion Criteria:
Known fixed stricture in the small intestine.
Former small bowel obstruction or obstructive symptoms.
Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
Colonic disease (except ileocecal valve area).
Anti-TNF treatment in the last 3 months.
Sensitivity or lack of response to previous adalimumab treatment.
Current gastrointestinal infection.
History of malignant disease (except BCC of skin).
Congestive heart failure, severe renal or hepatic dysfunction.
Patients suffering from tuberculosis, hepatitis B or C.
Pregnancy or unwillingness to use contraception during study period.
Dysphagia or swallowing disorders
Gastroparesis or severe gastrointestinal motility dysfunction.
Patients with cardiac pacemaker or implanted cardioverter devices.
Unable to sign informed consent.
Facility Information:
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petach Tikva
ZIP/Postal Code
4910
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
18034304
Citation
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. doi: 10.1007/s10620-007-0084-y. Epub 2007 Nov 22.
Results Reference
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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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