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Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

NCT ID: NCT01986127

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-14

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Crohn's Disease

Keywords

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Crohn disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Adalimumab

single administration of Adalimumab 80mg diluted in 5ml saline

Group Type EXPERIMENTAL

Adalimumab

Intervention Type DRUG

single intralesional administration during endoscopy process

saline

5 ml of saline

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single intralesional administration during endoscopy

Interventions

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Adalimumab

single intralesional administration during endoscopy process

Intervention Type DRUG

placebo

single intralesional administration during endoscopy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Sara Varea

OTHER

Sponsor Role lead

Responsible Party

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Sara Varea

Clinical Research Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Begoña González Suarez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Lucía Márquez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Alfredo Mata, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Sant Joan Despí Moisès Broggi

Carlos Huertas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Josep Trueta

Lidia Argüello, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital La Fe

Cecilia González, MD

Role: PRINCIPAL_INVESTIGATOR

Gregorio Marañón Hospital

Ana Echarri, MD

Role: PRINCIPAL_INVESTIGATOR

Complexo Hospitalario Arquitecto Marcide-Novoa Santos

Carme Loras

Role: PRINCIPAL_INVESTIGATOR

Hospital Mútua Terrassa

Maria D Martín Arranz

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Manuel Barreiro

Role: PRINCIPAL_INVESTIGATOR

Complexo Hospitalario de Santiago

Yago González

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta del Hierro

Beatriz Sicília

Role: PRINCIPAL_INVESTIGATOR

Complejo asistencial Universitario de Burgos

Sam Korrhami

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Espases

Ana Gutiérrez

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario de Alicante

Locations

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Complexo Hospitalario Arquitecto Marcide -Novoa Santos

Ferrol, A Coruña, Spain

Site Status

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital Moises Broggi

Sant Joan Despí, Barcelona, Spain

Site Status

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Site Status

Hospital Universitario Puerta del Hierro

Majadahonda, Madrid, Spain

Site Status

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, Spain

Site Status

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status

Hospital Clinic of Barcelona

Barcelona, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Complejo asistencial universitario de Burgos

Burgos, , Spain

Site Status

Hospital Josep Trueta

Girona, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2012-001723-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSAI

Identifier Type: -

Identifier Source: org_study_id