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A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World Setting
Sponsor: AbbVie
Summary
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.
Official title: Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2025-07-14
Completion Date
2027-12
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Locations (23)
Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706
Castellana Grotte, Bari, Italy
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216
Monserrato, Cagliari, Italy
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669
San Giovanni Rotondo, Foggia, Italy
Ospedale San Martino /ID# 274529
Genoa, Genova, Italy
IRCCS Istituto Clinico Humanitas /ID# 274489
Rozzano, Lombardy, Italy
IRCCS Ospedale San Raffaele /ID# 274458
Milan, Milano, Italy
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682
Monza, Monza E Brianza, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 274570
Naples, Napoli, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788
Naples, Napoli, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654
Rome, Roma, Italy
Ospedale Sandro Pertini /ID# 275023
Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530
Rome, Roma, Italy
A.O. Ordine Mauriziano di Torino /ID# 274459
Turin, Torino, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462
Negrar, Verona, Italy
A.O.U. Consorziale Policlinico di Bari /ID# 274662
Bari, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161
Bologna, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 274909
Catania, Italy
Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571
Catanzaro, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 274618
Milan, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964
Palermo, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488
Roma, Italy
Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966
Roma, Italy