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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.

Key facts

Who runs it
AbbVie
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
Trial code
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
Status
Recruiting
People taking part
250 people, planned
Started
14 Jul 2025
Expected to end
Dec 2027
Type of study
Observational, 2 groups
Record updated
24 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderate-to-severe Crohn's disease who were first treated with a TNF inhibitor and are now prescribed upadacitinib or risankizumab by their doctor.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Moderate-to-severe Crohn's disease, confirmed by clinical and/or endoscopic/histological indexes.
Earlier treatment
Must have taken a TNF inhibitor (TNF-i) as first treatment for at least 6 months, with medical records for the previous 2 years or since that treatment began. Must not have taken upadacitinib, risankizumab, or any approved or investigational non-TNFi biologic drug for Crohn's disease.

Main reasons for not taking part

  • Any condition listed in the warnings, precautions or contraindications of the approved local upadacitinib/risankizumab label
  • Earlier treatment with upadacitinib or risankizumab
  • Earlier treatment with any approved or investigational non-TNFi biologic drug for Crohn's disease

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

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

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • Upadacitinib

    Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months.

  • Risankizumab

    Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months.

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?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Observational Study of Upadacitinib or Risankizumab in Adults With Crohn's DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 June 2026