Under construction – not a live service
Sign in
Taking people in ItalyNo phase

Observational Study of Upadacitinib or Risankizumab in Adults With Crohn's Disease

Follows adults with Crohn's disease who are prescribed upadacitinib or risankizumab in routine care.

Plain-language title generated from the registry record
Registry 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

Key facts

Where
Bari, Bologna, Cagliari, Castellana Grotte, Catania, Catanzaro, Genova, Milan, Monserrato, Monza, Naples, Negrar, Palermo, Pescara, Roma, Rome, Rozzano, San Giovanni Rotondo, and Turin, ItalySee the 25 sites

Where in Italy

  • A.O.U. Consorziale Policlinico di Bari /ID# 274662Bari, ItalyTaking people
  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161Bologna, ItalyTaking people
  • Azienda Ospedaliera G. Brotzu /ID# 275125Cagliari, ItalyTaking people
  • Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706Castellana Grotte, ItalyTaking people
  • AOU Policlinico G. Rodolico - San Marco /ID# 274909Catania, ItalyTaking people
  • Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571Catanzaro, ItalyTaking people
  • Ospedale San Martino /ID# 274529Genova, ItalyTaking people
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618Milan, ItalyTaking people
  • IRCCS Ospedale San Raffaele /ID# 274458Milan, ItalyTaking people
  • Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216Monserrato, ItalyTaking people
  • Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682Monza, ItalyTaking people
  • Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570Naples, ItalyTaking people
  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788Naples, ItalyTaking people
  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462Negrar, ItalyTaking people
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964Palermo, ItalyTaking people
  • Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460Pescara, ItalyTaking people
  • Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966Roma, ItalyTaking people
  • Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488Roma, ItalyTaking people
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654Rome, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530Rome, ItalyTaking people
  • Ospedale Sandro Pertini /ID# 275023Rome, ItalyTaking people
  • IRCCS Istituto Clinico Humanitas /ID# 274489Rozzano, ItalyTaking people
  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669San Giovanni Rotondo, ItalyTaking people
  • A.O. Ordine Mauriziano di Torino /ID# 274459Turin, ItalyTaking people
  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461Turin, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
AbbVie
Trial code
NCT07073079
Record updated
24 June 2026
Original description
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.Read full original descriptionShow less

Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)

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.

Inclusion: 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: Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD; Any condition included in the "warning and precautions" and "contraindications" section of the approved local upadacitinib/risankizumab label.

ClinicalTrials.gov NCT07073079