Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01986127
• Other study ID #: CSAI
• Secondary ID: 2012-001723-12
• Status: Terminated
• Phase: Phase 3
• Start date: February 14, 2014
• Est. completion date: June 30, 2018

Study information

• Verified date: December 2018
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Adalimumab
single intralesional administration during endoscopy process
• placebo
single intralesional administration during endoscopy

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clinic of Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Complejo asistencial universitario de Burgos	Burgos
Spain	Complexo Hospitalario Arquitecto Marcide -Novoa Santos	Ferrol	A Coruña
Spain	Hospital Josep Trueta	Girona
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario Puerta del Hierro	Majadahonda	Madrid
Spain	Hospital Universitari Son Espases	Palma de Mallorca	Mallorca
Spain	Hospital Moises Broggi	Sant Joan Despí	Barcelona
Spain	Complexo Hospitalario Universitario de Santiago	Santiago de Compostela	A Coruña
Spain	Hospital Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Sara Varea	Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of endoscopic dilatation	Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis	at week 8
Secondary	Stenosis measure	The endoscopic stenosis diameter will be estimated pre and post-dilatation	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	proportion of patients that develop anti-adalimumab antibodies		at the end of the study
Secondary	adverse events		at the end of the study