Second-line treatment with upadacitinib or risankizumab for adults with Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, real-world study enrolling about 250 adults across roughly 25 sites in Italy who are prescribed upadacitinib or risankizumab by their treating physician. The study includes a retrospective review of up to 2 years of prior medical records and a prospective follow-up of up to 18 months after enrollment, with treatments given per local label and routine care. No experimental interventions or additional study-only procedures are required, and participants follow their usual clinical visits. Data collected will describe treatment responses, safety events, and treatment patterns for these two approved second-line options.

Why it matters

Who can join: the full rules

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's running

• Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706
  Castellana Grotte, Bari, Italy Recruiting
• Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216
  Monserrato, Cagliari, Italy Recruiting
• Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669
  San Giovanni Rotondo, Foggia, Italy Recruiting
• IRCCS Istituto Clinico Humanitas /ID# 274489
  Rozzano, Lombardy, Italy Recruiting
• IRCCS Ospedale San Raffaele /ID# 274458
  Milan, Milano, Italy Recruiting
• Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682
  Monza, Monza E Brianza, Italy Recruiting

Study contacts

• Study coordinator: Caterina Golotta
• Email: caterina.golotta@abbvie.com
• Phone: +39 06 548891

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.