NCT00553176

Brief Summary

The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6,273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1999

Longer than P75 for all trials

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

August 1, 1999

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

12.8 years

First QC Date

November 1, 2007

Last Update Submit

March 1, 2013

Conditions

Crohn's Disease

Keywords

InfliximabImmune disorderRemicadeRegistryCrohn's Disease

Outcome Measures

Primary Outcomes (1)

  • To document the variety of treatment regimens currently employed in the management of Crohn's disease

    Five years

Secondary Outcomes (4)

  • To assess clinical, economic, and humanistic outcomes of treatment

    Five years

  • To assess the long-term impact of various Crohn's disease treatment regimens

    Five years

  • To assess long-term outcomes specifically associated with the use of Remicade

    Five years

  • Collection of adverse events

    Five years

Study Arms (1)

Patients with Crohn's disease

The Registry is an observational research program featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease

Other: No intervention

Interventions

No interventionOTHER

At six-month intervals (January and July), physicians will document disease characteristics, changes in Crohn's therapy, disease progression, key events, the use of ancillary services, and hospitalizations

Patients with Crohn's disease

Eligibility Criteria

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

Adult patients diagnosed with Crohn's Disease

You may qualify if:

  • Patients must be diagnosed with Crohn's Disease

You may not qualify if:

  • Patients participating in clinical trials for Crohn's disease or other conditions also were not eligible to be enrolled in the TREAT™ Registry
  • Patients who are unable to participate in the program for 2 years or more.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn DiseaseImmune System Diseases

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Janssen Biotech, Inc. Clinical Trial

    Janssen Biotech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2007

First Posted

November 5, 2007

Study Start

August 1, 1999

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 4, 2013

Record last verified: 2013-03