Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Study Overview
=================
Brief 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)

Official Title
-----------------
A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Adalimumab
* Drug: placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab<br>single administration of Adalimumab 80mg diluted in 5ml saline | Drug: Adalimumab<br>* single intralesional administration during endoscopy process<br>|
| Placebo Comparator: saline<br>5 ml of saline | Drug: placebo<br>* single intralesional administration during endoscopy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of endoscopic dilatation | Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis | at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stenosis measure | The endoscopic stenosis diameter will be estimated pre and post-dilatation | 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 | 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 | 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) | at week 8 | 
| proportion of patients that develop anti-adalimumab antibodies |  | at the end of the study | 
| adverse events |  | at the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn disease