Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy

Crohn's Disease Clinical Trial

Official title:

Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01144156
• Other study ID #: Gal002
• Status: Not yet recruiting
• Phase: N/A
• First received: June 13, 2010
• Last updated: June 14, 2010

Study information

• Verified date: May 2010
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Ministry of Health.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Treatment 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

Locations

Country	Name	City	State
Israel	Rabin Medical Center - Beilinson Hospital	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Abbott

Country where clinical trial is conducted

Israel, 

References & 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. Epub 2007 Nov 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete mucosal healing	Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy	After 14 weeks of treatment	No
Secondary	Partial mucosal healing	Reduction of at least 50% in the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) after treatment.	After 14 weeks of treatment	No
Secondary	Correlation with clinical activity	Statistical correlation between CECDAI reduction and reduction in clinical (CDAI, IBDQ) and laboratory (CRP, calprotectin etc.) indices of disease activity.	After 14 weeks of treatment	No