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

NCT00723840 | Completed Results

• 1 other identifier: P04560
• Study Type: observational
• Target: 245
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease

Keywords

EuroQOL (EQ-5D)

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

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.

Interventions

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

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

Also known as: Crohn's Disease Participants

Crohn's Disease Participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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.S31114. Epub 2012 Jul 24.

  PMID: 22866007 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 30, 2015
• Results First Posted: April 29, 2011

Record last verified: 2015-07