Trial Outcomes & Findings for Assessment of the Social Cost of Crohn's Disease: Economic and Quality of Life Aspects (Study P04560) (NCT NCT00723840)

NCT ID: NCT00723840

Last Updated: 2015-07-30

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 245 participants
• Primary outcome timeframe: Baseline, 6, 12, and 18 months
• Results posted on: 2015-07-30

Participant Flow

Participant milestones

Measure	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, seen at one of 25 gastroenterology centers spread across Italy. 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.
Overall Study STARTED	245
Overall Study COMPLETED	163
Overall Study NOT COMPLETED	82

Reasons for withdrawal

Measure	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, seen at one of 25 gastroenterology centers spread across Italy. 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.
Overall Study Lost to Follow-up	2
Overall Study Failure to return	18
Overall Study Withdrawal by Subject	55
Overall Study Serious Adverse Events	3
Overall Study Other Medical Event	2
Overall Study Unspecified reason	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Crohn's Disease Participants n=162 Participants Participants with Crohn's Disease for at least 6 months, who have a Crohn's Disease Activity Index (CDAI) score \>= 150, seen at one of 25 gastroenterology centers spread across Italy. 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.
Age, Customized <18 years	0 participants n=113 Participants
Age, Customized Between 18 and 34 years	46 participants n=113 Participants
Age, Customized Between 35 and 44 years	43 participants n=113 Participants
Age, Customized Between 45 and 64 years	61 participants n=113 Participants
Age, Customized >=65 years	12 participants n=113 Participants
Sex: Female, Male Female	81 Participants n=113 Participants
Sex: Female, Male Male	81 Participants n=113 Participants
Region of Enrollment Italy	162 participants n=113 Participants

PRIMARY outcome

Timeframe: Baseline, 6, 12, and 18 months

Population: Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.

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.

Outcome measures

Measure	Baseline n=162 Participants Costs per participant at baseline in Euros	6 Months n=154 Participants Costs per participant at 6 months in Euros	12 Months n=154 Participants Costs per participant at 12 months in Euros	18 Months n=155 Participants Costs per participant at 18 months in Euros
Cost of Illness in Participants With Crohn's Disease Health care direct costs	6088.40 Euros	6169.62 Euros	5594.00 Euros	5825.80 Euros
Cost of Illness in Participants With Crohn's Disease Non-health care costs	1132.60 Euros	348.70 Euros	143.10 Euros	173.60 Euros
Cost of Illness in Participants With Crohn's Disease Costs for productivity loss	2173.00 Euros	1455.50 Euros	1199.10 Euros	740.20 Euros

PRIMARY outcome

Timeframe: Baseline, 6, 12, and 18 months

Population: Of the enrolled population, a total of 82 subjects interrupted the study prematurely. For one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis.

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.

Outcome measures

Measure	Baseline n=162 Participants Costs per participant at baseline in Euros	6 Months n=154 Participants Costs per participant at 6 months in Euros	12 Months n=154 Participants Costs per participant at 12 months in Euros	18 Months n=155 Participants Costs per participant at 18 months in Euros
EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease	0.558 Score on a scale	0.682 Score on a scale	0.728 Score on a scale	0.739 Score on a scale

Adverse Events

Crohn's Disease Participants

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Crohn's Disease Participants n=245 participants at risk Participants with Crohn's Disease for at least 6 months, who have a Crohn's Disease Activity Index (CDAI) score \>= 150, seen at one of 25 gastroenterology centers spread across Italy. 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.
Gastrointestinal disorders Intestinal stenosis	0.41% 1/245 • Number of events 1
General disorders Drug ineffective	0.41% 1/245 • Number of events 1
Infections and infestations Abdominal abscess	0.41% 1/245 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The disclosure restriction on the principal investigator (PI) is that the PI agrees not to publish or publicly present any results of the study without the prior written permission of the sponsor. The PI further agrees to allow the sponsor to review, 30 days prior to submission for publication or presentation, copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the study.
• Publication restrictions are in place

Restriction type: OTHER