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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
participant must:
Exclusion Criteria:
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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.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22866007 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Baseline characteristics for participants included in the pharmacoeconomic analysis. Of the enrolled population, a total of 82 subjects interrupted the study prematurely. In addition, for one participant, the age and sex were not available. These participants were not included in the pharmacoeconomic analysis. Therefore, the number of participants analyzed for this study is 162. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Euros | Baseline, 6, 12, and 18 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA (11.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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|
| Serious Adverse Events |
|
| Other Medical Event |
|
| Unspecified reason |
|
| Number |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 6 Months | Costs per participant at 6 months in Euros |
| OG002 | 12 Months | Costs per participant at 12 months in Euros |
| OG003 | 18 Months | Costs per participant at 18 months in 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. | 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. | Posted | Number | Score on a scale | Baseline, 6, 12, and 18 months |
|
|
|
| 3 |
| 245 |
| 0 |
| 245 |
| Drug ineffective | General disorders | MedDRA (11.1) |
|
| Abdominal abscess | Infections and infestations | MedDRA (11.1) |
|
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.