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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel
Complete mucosal healing
Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy
Time frame: After 14 weeks of treatment
Partial mucosal healing
Reduction of at least 50% in the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) after treatment.
Time frame: After 14 weeks of 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.
Time frame: After 14 weeks of treatment
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