Actively Recruiting
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
Led by AbbVie · Updated on 2026-02-24
250
Participants Needed
23
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults diagnosed with moderate-to-severe Crohn's Disease confirmed by clinical or endoscopic/histological measures
- Previously treated with Tumor Necrosis Factor inhibitor as first-line therapy for at least 6 months
- Clinical records available for the previous 2 years or since start of first-line therapy
You will not qualify if you...
- Any condition listed as a warning or contraindication in the approved upadacitinib or risankizumab labels
- Previous use of upadacitinib, risankizumab, or any approved or investigational non-TNF biologic Disease Modifying Antirheumatic Drug for Crohn's Disease
AI-Screening
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Trial Site Locations
Total: 23 locations
1
Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706
Castellana Grotte, Bari, Italy, 70013
Actively Recruiting
2
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216
Monserrato, Cagliari, Italy, 09042
Actively Recruiting
3
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669
San Giovanni Rotondo, Foggia, Italy, 71013
Actively Recruiting
4
Ospedale San Martino /ID# 274529
Genoa, Genova, Italy, 16132
Actively Recruiting
5
IRCCS Istituto Clinico Humanitas /ID# 274489
Rozzano, Lombardy, Italy, 20089
Actively Recruiting
6
IRCCS Ospedale San Raffaele /ID# 274458
Milan, Milano, Italy, 20132
Actively Recruiting
7
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682
Monza, Monza E Brianza, Italy, 20052
Actively Recruiting
8
Azienda Ospedaliera Universitaria Federico II /ID# 274570
Naples, Napoli, Italy, 80131
Actively Recruiting
9
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788
Naples, Napoli, Italy, 80138
Actively Recruiting
10
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461
Turin, Piedmont, Italy, 10126
Actively Recruiting
11
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654
Rome, Roma, Italy, 00133
Actively Recruiting
12
Ospedale Sandro Pertini /ID# 275023
Rome, Roma, Italy, 00157
Actively Recruiting
13
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530
Rome, Roma, Italy, 00168
Actively Recruiting
14
A.O. Ordine Mauriziano di Torino /ID# 274459
Turin, Torino, Italy, 10128
Actively Recruiting
15
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462
Negrar, Verona, Italy, 37024
Actively Recruiting
16
A.O.U. Consorziale Policlinico di Bari /ID# 274662
Bari, Italy, 70124
Actively Recruiting
17
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161
Bologna, Italy, 40138
Actively Recruiting
18
AOU Policlinico G. Rodolico - San Marco /ID# 274909
Catania, Italy, 95123
Actively Recruiting
19
Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571
Catanzaro, Italy, 88100
Actively Recruiting
20
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 274618
Milan, Italy, 20122
Actively Recruiting
21
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964
Palermo, Italy, 90146
Actively Recruiting
22
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488
Roma, Italy, 00128
Actively Recruiting
23
Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966
Roma, Italy, 00186
Actively Recruiting
Research Team
C
Caterina Golotta
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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