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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01605188
First Posted: May 24, 2012
Last Update Posted: January 28, 2016
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.
Information provided by (Responsible Party):
Nikos Viazis, Evangelismos Hospital
  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 Nikos Viazis, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 22, 2012
First Posted: May 24, 2012
Last Update Posted: January 28, 2016
Last Verified: January 2016

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