Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986127
Recruitment Status : Terminated (slow recruitment)
First Posted : November 18, 2013
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Sara Varea, Fundacion Clinic per a la Recerca Biomédica

Tracking Information
First Submitted Date  ICMJE October 9, 2013
First Posted Date  ICMJE November 18, 2013
Last Update Posted Date December 13, 2018
Study Start Date  ICMJE February 14, 2014
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
Success of endoscopic dilatation [ Time Frame: at week 8 ]
Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
  • Stenosis measure [ Time Frame: baseline ]
    The endoscopic stenosis diameter will be estimated pre and post-dilatation
  • success of endoscopic dilatation [ Time Frame: at week 52 ]
    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 ]
    • 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 ]
    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 ]
  • adverse events [ Time Frame: at the end of the study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients
Official Title  ICMJE A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Adalimumab
    single intralesional administration during endoscopy process
  • Drug: placebo
    single intralesional administration during endoscopy
Study Arms  ICMJE
  • Experimental: Adalimumab
    single administration of Adalimumab 80mg diluted in 5ml saline
    Intervention: Drug: Adalimumab
  • Placebo Comparator: saline
    5 ml of saline
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 11, 2018)
26
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2013)
102
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986127
Other Study ID Numbers  ICMJE CSAI
2012-001723-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sara Varea, Fundacion Clinic per a la Recerca Biomédica
Study Sponsor  ICMJE Sara Varea
Collaborators  ICMJE Hospital Clinic of Barcelona
Investigators  ICMJE
Principal Investigator: 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
PRS Account Fundacion Clinic per a la Recerca Biomédica
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP