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

Completed

• Conditions: Inflammatory Bowel Disease; Crohn's Disease

• Registration Number: NCT00723840
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-03-31
• Results First Submitted QC: 2011-03-31
• Results First Posted: 2011-04-29
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease	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.
Cost of Illness in Participants With Crohn's Disease	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.