Crohn's Disease, Inflammatory Bowel Disease
Conditions
Keywords
EuroQOL (EQ-5D)
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.
Detailed 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.
Interventions
OTHERObservational Studies: participants treated according to the real clinical practice.
No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost of Illness in Participants With Crohn's Disease | Baseline, 6, 12, and 18 months | 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. |
| EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease | Baseline, 6, 12, and 18 months | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 162 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Failure to return | 18 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other Medical Event | 2 |
| Overall Study | Serious Adverse Events | 3 |
| Overall Study | Unspecified reason | 2 |
| Overall Study | Withdrawal by Subject | 55 |
Baseline characteristics
| Characteristic | Crohn's Disease Participants |
|---|---|
| Age, Customized <18 years | 0 participants |
| Age, Customized >=65 years | 12 participants |
| Age, Customized Between 18 and 34 years | 46 participants |
| Age, Customized Between 35 and 44 years | 43 participants |
| Age, Customized Between 45 and 64 years | 61 participants |
| Region of Enrollment Italy | 162 participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 245 |
| serious Total, serious adverse events | 3 / 245 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Cost of Illness in Participants With Crohn's Disease | Health care direct costs | 6088.40 Euros |
| Baseline | Cost of Illness in Participants With Crohn's Disease | Costs for productivity loss | 2173.00 Euros |
| Baseline | Cost of Illness in Participants With Crohn's Disease | Non-health care costs | 1132.60 Euros |
| 6 Months | Cost of Illness in Participants With Crohn's Disease | Health care direct costs | 6169.62 Euros |
| 6 Months | Cost of Illness in Participants With Crohn's Disease | Costs for productivity loss | 1455.50 Euros |
| 6 Months | Cost of Illness in Participants With Crohn's Disease | Non-health care costs | 348.70 Euros |
| 12 Months | Cost of Illness in Participants With Crohn's Disease | Non-health care costs | 143.10 Euros |
| 12 Months | Cost of Illness in Participants With Crohn's Disease | Health care direct costs | 5594.00 Euros |
| 12 Months | Cost of Illness in Participants With Crohn's Disease | Costs for productivity loss | 1199.10 Euros |
| 18 Months | Cost of Illness in Participants With Crohn's Disease | Health care direct costs | 5825.80 Euros |
| 18 Months | Cost of Illness in Participants With Crohn's Disease | Costs for productivity loss | 740.20 Euros |
| 18 Months | Cost of Illness in Participants With Crohn's Disease | Non-health care costs | 173.60 Euros |
Primary
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baseline | EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease | 0.558 Score on a scale |
| 6 Months | EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease | 0.682 Score on a scale |
| 12 Months | EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease | 0.728 Score on a scale |
| 18 Months | EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease | 0.739 Score on a scale |