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Assessment of the Social Cost of Crohn's Disease: Economic and Quality of Life Aspects (Study P04560) (COSMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00723840
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : April 29, 2011
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
This observational study will evaluate the social cost and quality of life of participants who have had Crohn's Disease for at least 6 months and have active disease despite drug therapy. Participants are followed for a total of 18 months.

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Crohn's Disease Other: Observational Studies: participants treated according to the real clinical practice.

Detailed Description:
Participants for this study will be enrolled from 25 gastroenterology sites, even spread across Italy. Each center will enroll between 10 and 40 participants each.
Study Design
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Study Type : Observational
Actual Enrollment : 245 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Social Cost of Crohn's Disease (COsto Sociale Della Malattia di CrOhn - COSMO): Economic and Quality of Life Aspects
Study Start Date : September 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Groups and Cohorts
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Group/Cohort Intervention/treatment
Crohn's Disease Participants

Participants with Crohn's Disease for at least 6 months, who have a Crohn's Disease Activity Index (CDAI) score >= 150. The CDAI score evaluates Crohn's disease symptoms - a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

These participants have active disease despite drug therapy.

 Other: Observational Studies: participants treated according to the real clinical practice.
No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.
Other Name: Crohn's Disease Participants


Outcome Measures
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Primary Outcome Measures :
  1. Cost of Illness in Participants With Crohn's Disease [ Time Frame: Baseline, 6, 12, and 18 months ]

    Direct health care costs, non health care costs and costs for productivity loss were calculated by observation period in Crohn's Disease participants (in active phase) with a CDAI score >= 150.

    Direct health care costs refer to the resources used to prevent and treat a disease. Indirect costs include expenses for a participant's (or their caregiver's) transport, home assistance or home nursing assistance. Costs for productivity loss include the participant's (or their caregiver's) productivity loss or time loss.


  2. EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease [ Time Frame: Baseline, 6, 12, and 18 months ]

    EQ-5D was calculated for the pharmacoeconomics analysis to evaluate quality of life (QoL) in participants in the active phase with Crohn's Disease and had a CDAI score >= 150.

    EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Crohn's Disease for at least 6 months who have active disease despite drug therapy and are seen at one of 25 gastroenterology centers spread across Italy.
Criteria

Inclusion Criteria:

  • participant must:

    • be between 18 and 70 years of age,
    • have active Crohn's disease (CD) with CDAI score >= 150 (as per amended protocol) in spite of drug therapy, or active fistulizing disease,
    • be diagnosed with CD for at least 6 months,
    • sign the informed consent,
    • be capable of understanding the study and replying to the questionnaires.

Exclusion Criteria:

  • Participants who are unreliable in filling out questionnaires,
  • Participants with diseases which may interfere with the cost's of CD or its complications,
  • Participants who are participating in a clinical trial
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00723840    
Other Study ID Numbers: P04560
First Posted: July 29, 2008    Key Record Dates
Results First Posted: April 29, 2011
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by Merck Sharp & Dohme Corp.:
EuroQOL (EQ-5D)
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases