NCT01605175

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

May 22, 2012

Last Update Submit

November 15, 2015

Conditions

Inflammatory Bowel Disease

Keywords

Inflammatory Bowel DiseasePredictors Mucosal Healing

Outcome Measures

Primary Outcomes (1)

  • Endoscopical and histological mucosal healing

    12 weeks

Secondary Outcomes (1)

  • Endoscopical and histological mucosal healing

    52 weeks

Eligibility Criteria

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

Patients treated with anti-TNF in a tertiary hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with isolated fistulizing or stricturing or upper gastrointestinal Crohn disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelismos Hospital

Athens, 10676, 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, Director

    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
principal investigator - director gastrenterologist

Study Record Dates

First Submitted

May 22, 2012

First Posted

May 24, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

GR(1)