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

Crohn's Disease Clinical Trial

— COSMO  

Official title:

Assessment of the Social Cost of Crohn's Disease (COsto Sociale Della Malattia di CrOhn - COSMO): Economic and Quality of Life Aspects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723840
• Other study ID #: P04560
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: July 29, 2015
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Benedini V, Caporaso N, Corazza GR, Rossi Z, Fornaciari G, Cottone M, Frosini G, Caruggi M, Ottolini C, Colombo GL. Burden of Crohn's disease: economics and quality of life aspects in Italy. Clinicoecon Outcomes Res. 2012;4:209-18. doi: 10.2147/CEOR.S3111 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of Illness in Participants With Crohn's Disease	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.	Baseline, 6, 12, and 18 months	No
Primary	EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease	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.	Baseline, 6, 12, and 18 months	No