NCT01605188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

2.2 years

First QC Date

May 22, 2012

Last Update Submit

January 27, 2016

Conditions

Inflammatory Bowel Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IBD patients treated with anti-TNF that need dose escalation.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelismos Hospital

Athens, Greece

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Serum Bowel mucosal tissue

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Nikos Viazis

    Evangelismos Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consaltant Gastroenterologist

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

GR(1)