An observational study in Inflammatory Bowel Disease and Crohn's Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-30.
Sponsored by Merck Sharp & Dohme LLC · Observational
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 245 is above the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
participant must:
Exclusion Criteria:
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.
Other: Observational 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.
Also known as: Crohn's Disease Participants
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
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
| Milestone | Crohn's Disease Participants |
|---|---|
| Started | 245 |
| Completed | 163 |
| Not completed | 82 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Failure to return | 18 |
| Withdrew: Withdrawal by subject | 55 |
| Withdrew: Serious adverse events | 3 |
| Withdrew: Other medical event | 2 |
| Withdrew: Unspecified reason | 2 |
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.
| Euros | Baseline | 6 Months | 12 Months | 18 Months |
|---|---|---|---|---|
| Health care direct costs | 6088.40 | 6169.62 | 5594.00 | 5825.80 |
| Non-health care costs | 1132.60 | 348.70 | 143.10 | 173.60 |
| Costs for productivity loss | 2173.00 | 1455.50 | 1199.10 | 740.20 |
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.
| Score on a scale | Baseline | 6 Months | 12 Months | 18 Months |
|---|---|---|---|---|
| EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease | 0.558 | 0.682 | 0.728 | 0.739 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Crohn's Disease Participants | — | 3/245 (1.2%) | 0/245 (0%) |
| Event | Crohn's Disease Participants |
|---|---|
| Intestinal stenosisGastrointestinal disorders | 1/245 |
| Drug ineffectiveGeneral disorders | 1/245 |
| Abdominal abscessInfections and infestations | 1/245 |
| Age, Customized(participants) | Crohn's Disease Participants |
|---|---|
| <18 years | 0 |
| Between 18 and 34 years | 46 |
| Between 35 and 44 years | 43 |
| Between 45 and 64 years | 61 |
| >=65 years | 12 |
| Sex: Female, Male(Participants) | Crohn's Disease Participants |
|---|---|
| Female | 81 |
| Male | 81 |
| Region of Enrollment(participants) | Crohn's Disease Participants |
|---|---|
| Italy | 162 |
No study locations are listed for this record.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC