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

NCT ID: NCT00723840

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Observational Studies: participants treated according to the real clinical practice.

Intervention Type: OTHER

No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Crohn's Disease Participants

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.S31114. Epub 2012 Jul 24.

Reference Type: RESULT

PMID: 22866007 (View on PubMed)

Other Identifiers

P04560

Identifier Type: -

Identifier Source: org_study_id