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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nikos Viazis, Evangelismos Hospital
ClinicalTrials.gov Identifier:
NCT01605188
First received: May 22, 2012
Last updated: January 27, 2016
Last verified: January 2016
  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

Enrollment: 132
Study Start Date: May 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01605188

Locations
Greece
Evangelismos Hospital
Athens, Greece
Sponsors and Collaborators
Evangelismos Hospital
Investigators
Principal Investigator: Nikos Viazis Evangelismos Hospital
  More Information

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: January 27, 2016
Health Authority: Greece: Ethics Committee
Greece: Ministry of Health and Welfare

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

ClinicalTrials.gov processed this record on August 25, 2016