NCT01074580

Brief Summary

The purpose of this study is investigate if high frequency sonography and contrast enhanced sonography can be used to predict remission in patients with deterioration of Crohn's disease treated with steroids or tumor necrosis factor (TNF) alfa inhibitors.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

4.1 years

First QC Date

February 23, 2010

Last Update Submit

January 25, 2016

Conditions

Crohn's Disease

Keywords

Crohn's diseasesonographycontrast enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

  • Remission defined by Crohns disease activity index (CDAI)<150

    52 weeks from inclusion

Secondary Outcomes (2)

  • Surgical treatment for Crohn's disease during follow up. (Surgery for perianal disease not included.)

    52 weeks

  • Mucosal healing on ileocolonoscopy. Defined by Simple Endoscopic Index for Crohn's disease (SES-CD)

    12 weeks

Study Arms (1)

Deterioration, Crohn's disease

Patients \> 18 years old with a deterioration of Crohn's disease defined by CDAI \>150 and requiring treatment with systemic steroids or TNF alfa inhibitors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated for deterioration of Crohn's disease either in the out patient clinic or the medical ward of Haukeland University Hospital.

You may qualify if:

  • Deterioration of Crohn's disease
  • CDAI\>150
  • Treated with systemic steroids or TNF alfa inhibitors
  • Lesion found on ultrasound

You may not qualify if:

  • Disease location not reachable with ileocolonoscopy
  • Pregnancy
  • Acute coronary disease
  • Unstable coronary disease
  • Previous allergic reaction to SonoVue or its components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Haukeland University Hospital

Bergen, Hordaland, 5021, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Mucosal biopsies from the colon and terminal ileum.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Trygve Hausken, PhD

    Nastional Center of Gastroenterological Ultrasonography, Haukeland University Hospital, Bergen, Norway

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

NO(1)