Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166)
Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
This study is being done to assess the clinical course and treatment options for Crohn's Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East, and North Africa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2011
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 10, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJune 2, 2015
June 1, 2015
11 months
February 9, 2011
June 1, 2015
Conditions
Outcome Measures
Primary Outcomes (5)
The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites.
1 Year
The number of participants with different degrees of CD and UC severity.
1 Year
Use rates of classes of drug therapy.
1 Year
Number and types of surgical interventions.
1 Year
Outcomes of surgical intervention.
1 Year
Study Arms (1)
CD and UC participants
All participants with CD or UC visiting their physician over a period of one year, newly and already diagnosed, regardless of treatment pattern.
Interventions
There is no study intervention. Participants will be treated locally per site standards.
Eligibility Criteria
All patients with CD or UC who visit the study sites in Eastern Europe, Middle East, and North Africa during the study period will be asked to participate.
You may qualify if:
- Confirmed diagnosis of Crohn's disease or ulcerative colitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 10, 2011
Study Start
August 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
June 2, 2015
Record last verified: 2015-06