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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 March 2015 |
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Main ID: |
NCT01218360 |
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Date of registration:
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07/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)
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Scientific title:
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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) |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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71 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01218360 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Greece
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. Must have a diagnosis of active Crohn's Disease irrespective of severity,
2. Must be inadequately controlled with their current therapy and for whom physician
decides to switch treatment.
3. Must be between 18 and 65 years of age, of either sex,
4. Must demonstrate willingness to participate in the study by signing the written
informed consent.
Exclusion Criteria
- No specific exclusion criteria will be applied to a participant as long as the
participant is eligible for the trial
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: Physician standard-of-care
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Primary Outcome(s)
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Change in the CDAI score during the observational period
[Time Frame: Week 0 to 2 years]
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Record of treatment strategy followed
[Time Frame: Week 0 to 2 years]
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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.
[Time Frame: Week 0]
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Secondary Outcome(s)
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Number of surgeries and hospitalizations during the observational period
[Time Frame: Week 0 to 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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