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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Evangelismos Hospital.
Recruitment status was  Recruiting
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
  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
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: 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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014