Clinical trial NCT01986127: Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients
Official title: A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn disease
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2013-11-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Success of endoscopic dilatation
timeFrame: at week 8
Secondary outcomes:
measure: Stenosis measure
timeFrame: baseline
measure: success of endoscopic dilatation
timeFrame: at week 52
measure: Mucosal healing
timeFrame: at week 8
measure: Histological cure
timeFrame: at week 8
measure: proportion of patients that develop anti-adalimumab antibodies
timeFrame: at the end of the study
measure: adverse events
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Complexo Hospitalario Arquitecto Marcide -Novoa Santos
state: A Coruña
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
state: A Coruña
city: Sant Joan Despí
country: Spain
facility: Hospital Moises Broggi
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta del Hierro
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Mallorca
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Burgos
country: Spain
facility: Complejo asistencial universitario de Burgos
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Madrid
country: Spain
facility: Hospital La Paz
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Begoña González Suarez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Lucía Márquez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Sant Joan Despí Moisès Broggi
name: Alfredo Mata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Josep Trueta
name: Carlos Huertas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital La Fe
name: Lidia Argüello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gregorio Marañón Hospital
name: Cecilia González, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complexo Hospitalario Arquitecto Marcide-Novoa Santos
name: Ana Echarri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mútua Terrassa
name: Carme Loras
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz
name: Maria D Martín Arranz
role: PRINCIPAL_INVESTIGATOR
affiliation: Complexo Hospitalario de Santiago
name: Manuel Barreiro
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Puerta del Hierro
name: Yago González
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo asistencial Universitario de Burgos
name: Beatriz Sicília
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Espases
name: Sam Korrhami
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Alicante
name: Ana Gutiérrez
role: PRINCIPAL_INVESTIGATOR
References: