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Inflammatory Bowel Disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, relapsing, and often disabling condition characterized by inflammation of the gastrointestinal tract. A treat-to-target strategy (T2T) is recommended by international guidelines to optimize long-term outcomes in IBD. The purpose of this study is to describe the real-life implementation of T2T in IBD worldwide and the association between using a T2T strategy and disease outcomes.
This is a multi-country, observational, retrospective (non-interventional) study with a cross-sectional component based upon a sample of adult participants with IBD. All objectives will be assessed for IBD and then for CD/UC separately. Primary and secondary objectives will be assessed for the overall population over the 24 months study period.
As this is an observational study, enrolled participants will be managed and followed up according to the standard practice.
Retrospective chart review over the 24-months from date of inclusion will allow us to collect the variables of interest by using an e-CRF. There will be no additional burden for participants in this trial. Study visits will not be required as this is a retrospective chart review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with Inflammatory Bowel Disease | Participants will be managed and followed according to the standard practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Managed Using Treat-to-Target (T2T) | Defined as a participant with a therapeutic modification [dose escalation, change in therapy] within 12 weeks following any objective disease monitoring that demonstrated active disease. | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with a physician-confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) >= 2 years prior to enrolment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colla Cunneen | Contact | 708-650-3696 | colla.cunneen@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing General Hospital /ID# 282777 | Recruiting | Chongqing | Chongqing Municipality | 400013 | China | |
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| Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau /ID# 282775 |
| Not yet recruiting |
| Nîmes |
| Gard |
| 30029 |
| France |
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois /ID# 280265 | Not yet recruiting | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54511 | France |
| CHU Amiens-Picardie Site Sud /ID# 280263 | Not yet recruiting | Amiens | Somme | 80054 | France |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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