Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Evangelismos Hospital
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: February 11, 2015
Last verified: February 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


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (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
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: NCT01605175

Locations
Greece
Evangelismos Hospital Recruiting
Athens, Greece, 10676
Contact: Nikos Viazis    00306977617000    nikos.viazis@gmail.com   
Principal Investigator: Nikos Viazis, Director         
Sub-Investigator: Marios Giakoumis, Sinior         
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: February 11, 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 March 03, 2015