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
NCT ID: NCT07073079
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
250 participants
OBSERVATIONAL
2025-07-14
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Upadacitinib
Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months.
No interventions assigned to this group
Risankizumab
Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P25-397
Identifier Type: -
Identifier Source: org_study_id