Predictors of Mucosal Healing in Inflammatory Bowel Disease (IBD) Patients Treated With Anti-TNF

This study has been completed.
Sponsor:
Collaborators:
University of Athens
Laikon General District Hospital, Athens
Information provided by (Responsible Party):
Nikos Viazis, Evangelismos Hospital
ClinicalTrials.gov Identifier:
NCT01605175
First received: May 22, 2012
Last updated: November 15, 2015
Last verified: November 2015
  Purpose
The aim of this study is to prospectively identify, at diagnosis of the disease, factors predictive of mucosal healing 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 Tissue Healing in Inflammatory Bowel Disease Patients Treated With Anti-TNF

Further study details as provided by Evangelismos Hospital:

Primary Outcome Measures:
  • Endoscopical and histological mucosal healing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endoscopical and histological mucosal healing [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 21
Study Start Date: May 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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
Patients treated with anti-TNF in a tertiary hospital.
Criteria

Inclusion Criteria:

  • Patients with active Crohn luminal ileitis, colitis or ileocolitis necessitating therapy with anti-TNF, according to the physician's judgment, based on the current European Crohn's and Colitis Organisation (ECCO) guidelines.
  • Patients with corticosteroid resistant or corticosteroid dependent ulcerative colitis, necessitating therapy with anti-TNF, according to the physician's judgment, based on the current ECCO guidelines.

Exclusion Criteria:

  • Patients with isolated fistulizing or stricturing or upper gastrointestinal Crohn disease.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01605175

Locations
Greece
Evangelismos Hospital
Athens, Greece, 10676
Sponsors and Collaborators
Evangelismos Hospital
University of Athens
Laikon General District Hospital, Athens
Investigators
Principal Investigator: Nikos Viazis, Director Evangelismos Hospital
  More Information

No publications provided

Responsible Party: Nikos Viazis, principal investigator - director gastrenterologist, Evangelismos Hospital
ClinicalTrials.gov Identifier: NCT01605175     History of Changes
Other Study ID Numbers: nviazis 
Study First Received: May 22, 2012
Last Updated: November 15, 2015
Health Authority: Greece: Ethics Committee
Greece: Ministry of Health and Welfare

Keywords provided by Evangelismos Hospital:
Inflammatory Bowel Disease
Predictors Mucosal Healing

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

ClinicalTrials.gov processed this record on February 04, 2016