Title
Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients
A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients
Phase
Phase 3Lead Sponsor
University of BarcelonaStudy Type
InterventionalStatus
TerminatedIndication/Condition
Crohn's DiseaseIntervention/Treatment
adalimumab ...Study Participants
26We 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)
single intralesional administration during endoscopy process
single intralesional administration during endoscopy
single administration of Adalimumab 80mg diluted in 5ml saline
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
