N/A
N=245
Assessment of the Social Cost of Crohn's Disease: Economic and Quality of Life Aspects (Study P04560)
Inflammatory Bowel Disease · Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00723840 ↗Enrolled (actual)
245
Serious AEs
1.2%
Results posted
Apr 2011
Primary outcome: Primary: Cost of Illness in Participants With Crohn's Disease — 6088.40; 6169.62; 5594.00; 5825.80 Euros
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Observational Studies: participants treated according to the real clinical practice. (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cost of Illness in Participants With Crohn's Disease |
6088.40; 6169.62; 5594.00; 5825.80; 1132.60; 348.70 | — |
| PRIMARY EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease |
0.558; 0.682; 0.728; 0.739 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00723840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.