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
Recruiting · NCT07073079 · Observational (researchers observe without assigning treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- Participants with a diagnosis of moderate-to-severe Crohn's Disease (CD) confirmed by clinical, and/or endoscopic/histological indexes
- Participants previously treated with Tumor Necrosis Factor inhibitor (TNF-i) as fist line (1L) therapy for at least 6 months; clinical documentation available in medical charts for the previous 2 years or since the beginning of the 1L therapy
Exclusion criteria
- Any condition included in the "warning and precautions" and "contraindications" section of the approved local upadacitinib/risankizumab label
- Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD
Where it is running
25 locations listed.
- A.O.U. Consorziale Policlinico di Bari /ID# 274662 - Bari, Italy
- IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161 - Bologna, Italy
- Azienda Ospedaliera G. Brotzu /ID# 275125 - Cagliari, Italy
- AOU Policlinico G. Rodolico - San Marco /ID# 274909 - Catania, Italy
- Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571 - Catanzaro, Italy
- Ospedale San Martino /ID# 274529 - Genova, Italy
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618 - Milan, Italy
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964 - Palermo, Italy
- Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460 - Pescara, Italy
- Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488 - Roma, Italy
- Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966 - Roma, Italy
- 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
- 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 - Naples /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