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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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ClinicalTrials.gov Identifier: NCT01218360
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Crohn Disease Drug: Physician standard-of-care

Study Design

Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : November 2011
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Participants
All participants enrolled
Drug: Physician standard-of-care
Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Record of treatment strategy followed [ Time Frame: Week 0 to 2 years ]
  3. Change in the CDAI score during the observational period [ Time Frame: Week 0 to 2 years ]

Secondary Outcome Measures :
  1. Number of surgeries and hospitalizations during the observational period [ Time Frame: Week 0 to 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with diagnosed active Crohn's Disease who are inadequately controlled with their current therapy
Criteria

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
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01218360     History of Changes
Other Study ID Numbers: P06484
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Crohn's disease
standard-of-care
Crohn Disease
Active Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases