Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484)
Sponsor study identifier
observational
71
0 countries
N/A
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2010
Actual (reported)October 11, 2010
Actual (reported)November 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)January 2015
Actual (reported)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
Number of surgeries and hospitalizations during the observational period
Week 0 to 2 years
All participants enrolled
Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants with diagnosed active Crohn's Disease who are inadequately controlled with their current therapy
71 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2010
First Posted
October 11, 2010
Study Start
November 2011
Date type not reportedThis date has not been verified as actual or estimated.
Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
March 19, 2015
Record last verified: 2015-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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