Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients
- Registration Number
- NCT01986127
- Lead Sponsor
- Sara Varea
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description saline placebo 5 ml of saline Adalimumab Adalimumab single administration of Adalimumab 80mg diluted in 5ml saline
- Primary Outcome Measures
Name Time Method Success of endoscopic dilatation at week 8 Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis
- Secondary Outcome Measures
Name Time Method 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 treatmentproportion of patients that develop anti-adalimumab antibodies at the end of the study Stenosis measure baseline The endoscopic stenosis diameter will be estimated pre and post-dilatation
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)adverse events at the end of the study
Trial Locations
- Locations (13)
Hospital Moises Broggi
🇪🇸Sant Joan Despí, Barcelona, Spain
Complexo Hospitalario Arquitecto Marcide -Novoa Santos
🇪🇸Ferrol, A Coruña, Spain
Complexo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital Universitario Puerta del Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitari Son Espases
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Clinic of Barcelona
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Josep Trueta
🇪🇸Girona, Spain
Complejo asistencial universitario de Burgos
🇪🇸Burgos, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital La Paz
🇪🇸Madrid, Spain