Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Phase 3TerminatedNCT01986127

Sara Varea26 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Crohn's Disease

Interventions

AdalimumabDRUG

single intralesional administration during endoscopy process

placeboDRUG

single intralesional administration during endoscopy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Complexo Hospitalario Arquitecto Marcide -Novoa Santos

Ferrol, A Coruña, Spain

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Hospital Moises Broggi

Sant Joan Despí, Barcelona, Spain

Outcomes

Primary Outcomes

Success of endoscopic dilatation

Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis

Time frame: at week 8

Secondary Outcomes

Stenosis measure

The endoscopic stenosis diameter will be estimated pre and post-dilatation

Time frame: baseline

success of endoscopic dilatation

The success of endoscopic dilatation at week 52 means absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation

Time frame: at week 52

Mucosal healing

* Anastomotic strictures: We define mucosal healing as a Rutgeerts \< or equal 2 with at least 1 point of improvement (añadir el score) * Primary strictures: Absence of ulcers after treatment

Time frame: at week 8

Histological cure

We consider histological cure if: * Epithelial damage is \< or equal 1 * Architectural changes is \< or equal 1 * Infiltration of mononuclear cells in lamina propria is \< or equal 1 * Polymorphonuclear cells in the lamina propria = 0 * Polymorphonuclear cells in epithelium = 0 * Absence of erosions and ulcers (based ib scoring system for Histologic Abnormalities in Crohn's disease Mucosal Biopsy Specimens - Title: Early lesions of recurrent Crohn's disease caused by infusion of intestinal contents in excluded ileum Author(s): D'Haens, Geert R.; Geboes, Karel; Peeters, Mark; et al. Source: Gastroenterology Volume: 114 Issue: 2 Pages: 262-267 Published: Feb., 1998)

Time frame: at week 8

proportion of patients that develop anti-adalimumab antibodies

Time frame: at the end of the study

Data from ClinicalTrials.gov

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