NCT00819663

Brief Summary

Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response and can be detected in patients undergoing serial computed tomography enterography (CTE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

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

First Submitted

Initial submission to the registry

January 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 19, 2011

Status Verified

August 1, 2011

Enrollment Period

1.5 years

First QC Date

January 7, 2009

Last Update Submit

August 17, 2011

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response and can be detected in patients undergoing serial computed tomography enterography (CTE).

    2004-2008

Study Arms (1)

Crohns patients

Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

(Retrospectively) Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy.

You may qualify if:

  • Established Crohn's disease
  • CTE before and after initiating infliximab
  • Underwent at least 2 CTEs between 1/1/2004 and 12/31/2007
  • At least 6 months between CTEs

You may not qualify if:

  • Small bowel surgery occurring before repeat CTE imaging
  • Episodic infliximab therapy (intervals greater than every 8 weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Bruining DH, Loftus EV Jr, Ehman EC, Siddiki HA, Nguyen DL, Fidler JL, Huprich JE, Mandrekar JN, Harmsen WS, Sandborn WJ, Fletcher JG. Computed tomography enterography detects intestinal wall changes and effects of treatment in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2011 Aug;9(8):679-683.e1. doi: 10.1016/j.cgh.2011.04.025. Epub 2011 May 5.

    PMID: 21621641RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • David H Bruining, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 9, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 19, 2011

Record last verified: 2011-08

Locations

US(1)