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Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Collaborator:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01986127
First received: October 9, 2013
Last updated: August 20, 2014
Last verified: July 2014
  Purpose

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)


Condition Intervention Phase
Crohn's Disease
Drug: Adalimumab
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Success of endoscopic dilatation [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
    Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis


Secondary Outcome Measures:
  • Stenosis measure [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The endoscopic stenosis diameter will be estimated pre and post-dilatation

  • success of endoscopic dilatation [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
    The success of endoscopic dilatation at week 52 means absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation

  • Mucosal healing [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
    • 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

  • Histological cure [ Time Frame: at week 8 ] [ Designated as safety issue: No ]

    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)

  • proportion of patients that develop anti-adalimumab antibodies [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: at the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 102
Study Start Date: February 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab
single administration of Adalimumab 80mg diluted in 5ml saline
Drug: Adalimumab
single intralesional administration during endoscopy process
Placebo Comparator: saline
5 ml of saline
Drug: placebo
single intralesional administration during endoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986127

Contacts
Contact: Begoña Gonzalez Suarez, MD BGONZALS@CLINIC.UB.ES
Contact: Sara Varea Latorre, BSc svarea@clinic.ub.es

Locations
Spain
Complexo Hospitalario Arquitecto Marcide -Novoa Santos Not yet recruiting
Ferrol, A Coruña, Spain, 15405
Contact: Ana Echarri, MD       ana.echarri.piudo@sergas.es   
Principal Investigator: Ana Echarri, MD         
Hospital Parc Taulí Not yet recruiting
Sabadell, Barcelona, Spain, 08208
Contact: Enric Brullet, MD       ebrullet@tauli.cat   
Principal Investigator: Enric Brullet, MD         
Hospital Moises Broggi Active, not recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Begoña Gonzalez Suarez, MD       BGONZALS@clinic.ub.es   
Principal Investigator: Begoña Gonzalez Suarez, MD         
Hospital del Mar Active, not recruiting
Barcelona, Spain
Hospital Josep Trueta Active, not recruiting
Girona, Spain, 17007
Hospital La Fe Not yet recruiting
Valencia, Spain, 46026
Contact: Lidia Argüello, MD       arguello_lid@gva.es   
Principal Investigator: Lidia Argüello, MD         
Sponsors and Collaborators
Sara Varea
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Begoña González Suarez, MD Hospital Clinic of Barcelona
Principal Investigator: Lucía Márquez, MD Hospital del Mar
Principal Investigator: Alfredo Mata, MD Hospital Moisés Broggi
Principal Investigator: Carlos Huertas, MD Hospital Josep Trueta
Principal Investigator: Lidia Argüello, MD Hospital La Fe
Principal Investigator: Enric Brullet, MD Hospital Parc Taulí
Principal Investigator: Cecilia González, MD Hospital Gregorio Marañón
Principal Investigator: Ana Echarri, MD Complexo Hospitalario Arquitecto Marcide-Novoa Santos
  More Information

No publications provided

Responsible Party: Sara Varea, Clinical Research Manager, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01986127     History of Changes
Other Study ID Numbers: CSAI, 2012-001723-12
Study First Received: October 9, 2013
Last Updated: August 20, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
Crohn disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014