Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2010
CompletedFirst Posted
Study publicly available on registry
June 15, 2010
CompletedJune 15, 2010
May 1, 2010
June 13, 2010
June 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete mucosal healing
Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy
After 14 weeks of treatment
Secondary Outcomes (2)
Partial mucosal healing
After 14 weeks of treatment
Correlation with clinical activity
After 14 weeks of treatment
Interventions
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
Eligibility Criteria
You may qualify if:
- Isolated small bowel Crohn's disease.
- Age ≥18.
- Active disease (CDAI≥220).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Abbottcollaborator
Study Sites (1)
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4910, Israel
Related Publications (1)
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.
PMID: 18034304BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 13, 2010
First Posted
June 15, 2010
Last Updated
June 15, 2010
Record last verified: 2010-05