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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Inflammatory Bowel Disease; Crohn's Disease

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00723840

P04560

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

245 participants in 1 patient group

Crohn's Disease Participants

Description:

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.

Treatment:

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