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Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD).
Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium.
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib | Participants will receive upadacitinib as prescribed by their physician according to local label. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission as per Partial Adapted Mayo Subscores for Ulcerative Colitis | Clinical remission is defined as: stool frequency (SF) score < = 1 and not greater than baseline and Rectal bleeding (RB) score = 0 | Up to approximately 52 weeks |
| Percentage of Participants Achieving Clinical Remission as per Patient Reported Outcome (PRO2) for Crohn's Disease | Clinical remission is defined as stool frequency (SF) score < =3 and not worse than baseline and Abdominal Pain (AP) score < =1 and not worse than baseline | Up to approximately 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with ulcerative colitis or Crohn's Disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liesbeth Ghys | Contact | 844-663-3742 | liesbeth.ghys@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Ziekenhuis /ID# 268631 | Recruiting | Bonheiden | Antwerpen | 2820 | Belgium | |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Universite Libre de Bruxelles - Hopital Erasme /ID# 268632 |
| Recruiting |
| Anderlecht |
| Brussels Capital |
| 1070 |
| Belgium |
| CHU de Liège /ID# 267209 | Recruiting | Liège | Liege | 4000 | Belgium |
| UZ Gent /ID# 268630 | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Vitaz /Id# 268637 | Recruiting | Sint-Niklaas | Oost-Vlaanderen | 9100 | Belgium |
| AZ Groeninge /ID# 268638 | Recruiting | Kortrijk | West-Vlaanderen | 8500 | Belgium |
| Groupe Sante CHC - Clinique du MontLegia /ID# 268662 | Recruiting | Liège | 4000 | Belgium |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |