RecruitingRecruiting
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
NCT07073079 · AbbVie
In plain English
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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)
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 250 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-07-14
Estimated completion: 2027-12
Last updated: 2026-06-24
Primary outcomes
- • Percentage of Participants who Achieve Corticosteroids (CS) Free Remission (Month 12)
Sponsor
AbbVie · industry
Contacts & investigators
ContactCaterina Golotta · contact · caterina.golotta@abbvie.com · +39 06 548891
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (25)
Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706Recruiting
Castellana Grotte, Bari, Italy
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216Recruiting
Monserrato, Cagliari, Italy
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669Recruiting
San Giovanni Rotondo, Foggia, Italy
IRCCS Istituto Clinico Humanitas /ID# 274489Recruiting
Rozzano, Lombardy, Italy
IRCCS Ospedale San Raffaele /ID# 274458Recruiting
Milan, Milano, Italy
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682Recruiting
Monza, Monza E Brianza, Italy
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570Recruiting
Naples, Napoli, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788Recruiting
Naples, Napoli, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461Recruiting
Turin, Piedmont, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654Recruiting
Rome, Roma, Italy
Ospedale Sandro Pertini /ID# 275023Recruiting
Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530Recruiting
Rome, Roma, Italy
A.O. Ordine Mauriziano di Torino /ID# 274459Recruiting
Turin, Torino, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462Recruiting
Negrar, Verona, Italy
A.O.U. Consorziale Policlinico di Bari /ID# 274662Recruiting
Bari, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161Recruiting
Bologna, Italy
Azienda Ospedaliera G. Brotzu /ID# 275125Recruiting
Cagliari, Italy
AOU Policlinico G. Rodolico - San Marco /ID# 274909Recruiting
Catania, Italy
Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571Recruiting
Catanzaro, Italy
Ospedale San Martino /ID# 274529Recruiting
Genova, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618Recruiting
Milan, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964Recruiting
Palermo, Italy
Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460Recruiting
Pescara, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488Recruiting
Roma, Italy
Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966Recruiting
Roma, Italy