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

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723840

Purpose

This observational study will evaluate the social cost and quality of life of patients who have had Crohn's Disease for at least 6 months and have active disease despite drug therapy. Patients are followed for a total of 18 months.

Condition	Intervention
Inflammatory Bowel Disease Crohn's Disease	Other: Observational Studies: patients treated according to the real clinical practice.

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	COsto Sociale Della Malattia di CrOhn - COSMO: Aspetti Economici e di qualità Della Vita

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Questionnaires: Economic questionnaire in the case report form, European Quality of Life (EuroQOL), Short Form 36 (SF-36), and Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline, 6, 12, and 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	September 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Crohn's Disease Patients 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.	Other: Observational Studies: patients treated according to the real clinical practice. Subject can be on any drug therapy as long as subject has active Crohn's Disease Activity Index (CDAI) score >= 150 (as per amended protocol) in spite of drug therapy, or fistulizing disease

Detailed Description:

Subjects for this study will be enrolled from 25 gastroenterology sites, even spread across Italy. Each center will enroll between 10 and 40 subjects each.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria:

Subject 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,
- been 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:

Subjects who are unreliable in filling out questionnaires,
Subjects with diseases which may interfere with the cost's of CD or its complications,
Subjects who are participating in a clinical trial

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04560
Study First Received:	July 25, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00723840
Health Authority:	Italy: A.S.O. Ordine Mauriziano - Torino

Keywords provided by Schering-Plough:

IBDQ
SF 12
EuroQOL (EQ 5 D)

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Quality of Life

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009