NCT01218360

Brief Summary

This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Typical duration 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

First Submitted

Initial submission to the registry

October 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

October 7, 2010

Last Update Submit

March 18, 2015

Conditions

Crohn Disease

Keywords

Crohn's diseasestandard-of-careCrohn DiseaseActive Crohn's Disease

Outcome Measures

Primary Outcomes (3)

  • Percentage of Crohn's disease participants among the study population with a Crohn's Disease Activity Index (CDAI) score of 220-450 at the enrollment to the study.

    Week 0

  • Record of treatment strategy followed

    Week 0 to 2 years

  • Change in the CDAI score during the observational period

    Week 0 to 2 years

Secondary Outcomes (1)

  • Number of surgeries and hospitalizations during the observational period

    Week 0 to 2 years

Study Arms (1)

Participants

All participants enrolled

Drug: Physician standard-of-care

Interventions

Physician standard-of-careDRUG

Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).

Participants

Eligibility Criteria

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

Participants with diagnosed active Crohn's Disease who are inadequately controlled with their current therapy

You may qualify if:

  • Must have a diagnosis of active Crohn's Disease irrespective of severity,
  • Must be inadequately controlled with their current therapy and for whom physician
  • decides to switch treatment.
  • Must be between 18 and 65 years of age, of either sex,
  • Must demonstrate willingness to participate in the study by signing the written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

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

Study Record Dates

First Submitted

October 7, 2010

First Posted

October 11, 2010

Study Start

November 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 19, 2015

Record last verified: 2015-03