Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.