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

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ClinicalTrials.gov Identifier: NCT01605188
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Nikos Viazis, Evangelismos Hospital

Brief Summary:
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 or disease
Inflammatory Bowel Disease

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Predictors of Non-response and Loss of Response in IBD Patients Treated With Anti-TNF.
Study Start Date : May 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014



Biospecimen Retention:   Samples With DNA
Whole blood Serum Bowel mucosal tissue


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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.

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

Responsible Party: Nikos Viazis, Consaltant Gastroenterologist, Evangelismos Hospital
ClinicalTrials.gov Identifier: NCT01605188     History of Changes
Other Study ID Numbers: nviazis2
First Posted: May 24, 2012    Key Record Dates
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