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Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will evaluate the second line effectiveness of upadacitinib and risankizumab in Crohn's Disease (CD) in a real-world setting.
Upadacitinib and risankizumab are approved drugs for treating CD. Approximately 250 participants who are prescribed upadacitinib or risankizumab by their physician in accordance with local label will be enrolled in 25 sites across Italy.
Participants will receive upadacitinib or risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 18 months.
No additional burden for participants in this trial is expected.
The retrospective phase will be up to 2 years prior to enrollment to the study, the prospective phase will be up to 18 months after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upadacitinib | Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months. | ||
| Risankizumab | Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve Corticosteroids (CS) Free Remission | CS free remission is defined as clinical remission with Harvey Bradshaw Index (HBI) <4 and absence of corticosteroid use since at least three months prior to month 12. | Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with Crohn's Disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caterina Golotta | Contact | +39 06 548891 | caterina.golotta@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706 | Recruiting | Castellana Grotte | Bari | 70013 | Italy |
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| Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216 | Recruiting | Monserrato | Cagliari | 09042 | Italy |
| Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669 | Recruiting | San Giovanni Rotondo | Foggia | 71013 | Italy |
| IRCCS Istituto Clinico Humanitas /ID# 274489 | Recruiting | Rozzano | Lombardy | 20089 | Italy |
| IRCCS Ospedale San Raffaele /ID# 274458 | Recruiting | Milan | Milano | 20132 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682 | Recruiting | Monza | Monza E Brianza | 20052 | Italy |
| Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570 | Recruiting | Naples | Napoli | 80131 | Italy |
| Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788 | Recruiting | Naples | Napoli | 80138 | Italy |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461 | Recruiting | Turin | Piedmont | 10126 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654 | Recruiting | Rome | Roma | 00133 | Italy |
| Ospedale Sandro Pertini /ID# 275023 | Recruiting | Rome | Roma | 00157 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530 | Recruiting | Rome | Roma | 00168 | Italy |
| A.O. Ordine Mauriziano di Torino /ID# 274459 | Recruiting | Turin | Torino | 10128 | Italy |
| IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462 | Recruiting | Negrar | Verona | 37024 | Italy |
| A.O.U. Consorziale Policlinico di Bari /ID# 274662 | Recruiting | Bari | 70124 | Italy |
| IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161 | Recruiting | Bologna | 40138 | Italy |
| Azienda Ospedaliera G. Brotzu /ID# 275125 | Recruiting | Cagliari | 09047 | Italy |
| AOU Policlinico G. Rodolico - San Marco /ID# 274909 | Recruiting | Catania | 95123 | Italy |
| Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571 | Recruiting | Catanzaro | 88100 | Italy |
| Ospedale San Martino /ID# 274529 | Recruiting | Genova | 16132 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618 | Recruiting | Milan | 20122 | Italy |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964 | Recruiting | Palermo | 90146 | Italy |
| Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460 | Recruiting | Pescara | 65124 | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488 | Recruiting | Roma | 00128 | Italy |
| Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966 | Recruiting | Roma | 00186 | Italy |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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