Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

• Status: Terminated
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sara Varea
• Collaborator: Hospital Clinic of Barcelona
• Treatments: Adalimumab

Criteria

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

Exclusion Criteria:

• Patients with large intestinal stenosis (more than 6cm) and multiples

• Patients with previous or actual treatment with anti-tumor necrosis factor (anti-TNF) drugs

• Patients with positive serology to hepatitis B virus(HBV),hepatitis C virus (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