Crohn's Disease
Conditions
Keywords
Crohn's disease, Small bowel, Mucosal healing, Capsule endoscopy, Adalimumab, Small bowel Crohn's disease
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.
Interventions
DRUGTreatment 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
Sponsors
Abbott
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete mucosal healing | After 14 weeks of treatment | Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partial mucosal healing | 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 | 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. |
Countries
Israel
Outcome results
None listed