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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00723840
First received: July 25, 2008
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Cost of Illness in Participants With Crohn's Disease [ Time Frame: Baseline, 6, 12, and 18 months ] [ Designated as safety issue: No ]

    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.


  • EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease [ Time Frame: Baseline, 6, 12, and 18 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 245
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme
ClinicalTrials.gov Identifier: NCT00723840     History of Changes
Other Study ID Numbers: P04560
Study First Received: July 25, 2008
Results First Received: March 31, 2011
Last Updated: May 10, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Schering-Plough:
EuroQOL (EQ-5D)

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

ClinicalTrials.gov processed this record on May 23, 2013