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.
Study Type
OBSERVATIONAL
Enrollment
250
Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706
Castellana Grotte, Bari, Italy
RECRUITINGAzienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216
Monserrato, Cagliari, Italy
RECRUITINGFondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669
San Giovanni Rotondo, Foggia, Italy
RECRUITINGIRCCS Istituto Clinico Humanitas /ID# 274489
Rozzano, Lombardy, Italy
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.
Time frame: Month 12
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IRCCS Ospedale San Raffaele /ID# 274458
Milan, Milano, Italy
RECRUITINGFondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682
Monza, Monza E Brianza, Italy
RECRUITINGAzienda Ospedaliera Universitaria Federico II - Naples /ID# 274570
Naples, Napoli, Italy
RECRUITINGAzienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788
Naples, Napoli, Italy
RECRUITINGA.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461
Turin, Piedmont, Italy
RECRUITINGAzienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654
Rome, Roma, Italy
RECRUITING...and 15 more locations