Crohn's Disease
Conditions
Keywords
Crohn disease
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)
Interventions
DRUGAdalimumab
single intralesional administration during endoscopy process
DRUGplacebo
single intralesional administration during endoscopy
Sponsors
Hospital Clinic of Barcelona
Sara Varea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of endoscopic dilatation | at week 8 | Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| success of endoscopic dilatation | at week 52 | The success of endoscopic dilatation at week 52 means absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation |
| Mucosal healing | at week 8 | * 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 |
| Stenosis measure | baseline | The endoscopic stenosis diameter will be estimated pre and post-dilatation |
| proportion of patients that develop anti-adalimumab antibodies | at the end of the study | — |
| adverse events | at the end of the study | — |
| Histological cure | at week 8 | 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) |
Countries
Spain
Outcome results
None listed