adalimumab intralesional in intestinal strictures of Crohn's disease patients

Phase 1

Conditions: Crohn disease
MedDRA version: 16.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Registration Number: EUCTR2012-001723-12-ES

Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 102

Inclusion Criteria

-Patients of both sexes older than 18 years
-Patient diagnosed of CROHN´s disease
-Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum)
-Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy)
-Dilated stenosis according to endoscopist criteria (pass or no the endoscopy)
-Patient capable of participate in the examinations required by the study
-Patient after being informed, give his/her informed consent in writing
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

-Patients with large intestinal stenosis (more than 6cm) and multiples
-Patients with previous or actual treatment with anti-TNF drugs
-Patients with positive serology to HBV,HCV, or HIV
-Patients with positive screening to Tuberculosis(positive PPD)
-Established contraindication to anti-TNF drugs
-Existence of fistulous tracts associated with intestinal stenosis
-Neoplastic process associated with stenosis or in another location
-Pregnancy or breastfeeding