Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

NCT01986127 | Terminated Phase 3

• 2 other identifiers: CSAI2012-001723-12
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 13

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)

Conditions

Crohn's Disease

Keywords

Crohn disease

Outcome Measures

Primary Outcomes (1)

• Success of endoscopic dilatation

  Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis

  at week 8

Secondary Outcomes (6)

• Stenosis measure

  baseline

• success of endoscopic dilatation

  at week 52

• Mucosal healing

  at week 8

• Histological cure

  at week 8

• proportion of patients that develop anti-adalimumab antibodies

  at the end of the study

Study Arms (2)

Adalimumab

EXPERIMENTAL

single administration of Adalimumab 80mg diluted in 5ml saline

Drug: Adalimumab

saline

PLACEBO COMPARATOR

5 ml of saline

Drug: placebo

Interventions

Adalimumab DRUG

single intralesional administration during endoscopy process

Adalimumab

placebo DRUG

single intralesional administration during endoscopy

saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Varea: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (13)

Complexo Hospitalario Arquitecto Marcide -Novoa Santos

Ferrol, A Coruña, 15405, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Moises Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario Puerta del Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, 07120, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Complejo asistencial universitario de Burgos

Burgos, 09005, Spain

Location

Hospital Josep Trueta

Girona, 17007, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Begoña González Suarez, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Lucía Márquez, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Alfredo Mata, MD

  Hospital de Sant Joan Despí Moisès Broggi

  PRINCIPAL INVESTIGATOR

• Carlos Huertas, MD

  Hospital Josep Trueta

  PRINCIPAL INVESTIGATOR

• Lidia Argüello, MD

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

• Cecilia González, MD

  Gregorio Marañón Hospital

  PRINCIPAL INVESTIGATOR

• Ana Echarri, MD

  Complexo Hospitalario Arquitecto Marcide-Novoa Santos

  PRINCIPAL INVESTIGATOR

• Carme Loras

  Hospital Mútua Terrassa

  PRINCIPAL INVESTIGATOR

• Maria D Martín Arranz

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Manuel Barreiro

  Complexo Hospitalario de Santiago

  PRINCIPAL INVESTIGATOR

• Yago González

  Hospital Universitario Puerta del Hierro

  PRINCIPAL INVESTIGATOR

• Beatriz Sicília

  Complejo asistencial Universitario de Burgos

  PRINCIPAL INVESTIGATOR

• Sam Korrhami

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

• Ana Gutiérrez

  Hospital General Universitario de Alicante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: November 18, 2013
• Study Start: February 14, 2014
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

ES (13)