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Predictors of Non-response and Loss of Response in IBD Patients Treated With Anti-TNF

This study is currently recruiting participants.
Verified July 2012 by Evangelismos Hospital
Sponsor:
Information provided by (Responsible Party):
Nikos Viazis, Evangelismos Hospital
ClinicalTrials.gov Identifier:
NCT01605188
First received: May 22, 2012
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

The aim of our study is to prospectively identify, at diagnosis, factors predictive of non-response or loss of response in patients with inflammatory bowel disease treated with anti-TNF.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Predictors of Non-response and Loss of Response in IBD Patients Treated With Anti-TNF.

Further study details as provided by Evangelismos Hospital:

Biospecimen Retention:   Samples With DNA

Whole blood Serum Bowel mucosal tissue


Estimated Enrollment: 10
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

IBD patients treated with anti-TNF that need dose escalation.

Criteria

Inclusion Criteria:

  • Active Crohn's luminal ileitis, colitis or ileocolitis necessitating therapy with anti-TNF, according to the physician's judgment, based on the current ECCO guidelines.
  • Corticosteroid resistant or corticosteroid dependent ulcerative colitis, necessitating therapy with anti-TNF, according to the physician's judgment, based on the current ECCO guidelines.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605188

Contacts
Contact: Nikos Viazis 00306977617000 nikos.viazis@gmail.com

Locations
Greece
Evangelismos Hospital Recruiting
Athens, Greece
Contact: Nikos Viazis, Consultant     0036977617000     nikos.viazis@gmail.com    
Contact: Theodoros Koukouratos, Senior         a.koukouratos@yahoo.gr    
Principal Investigator: Nikos Viazis            
Sub-Investigator: Theodoros Koukouratos            
Sponsors and Collaborators
Evangelismos Hospital
Investigators
Principal Investigator: Nikos Viazis Evangelismos Hospital
  More Information

No publications provided

Responsible Party: Nikos Viazis, Consaltant Gastroenterologist, Evangelismos Hospital
ClinicalTrials.gov Identifier: NCT01605188     History of Changes
Other Study ID Numbers: nviazis2
Study First Received: May 22, 2012
Last Updated: July 26, 2012
Health Authority: Greece: Ethics Committee
Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013