RecruitingNCT07073079

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

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

Sponsor

AbbVie

Enrollment

250 participants

Start Date

Jul 14, 2025

Study Type

OBSERVATIONAL

Conditions

Crohn's Disease

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well two treatments — upadacitinib and risankizumab — work as a second treatment option for adults with moderate-to-severe Crohn's disease in real-world settings. **You may be eligible if...** - You are an adult with moderate-to-severe Crohn's disease confirmed by clinical, endoscopic, or tissue testing - You previously received a TNF-blocker (like adalimumab or infliximab) as your first treatment for at least 6 months - Your medical records from the past 2 years (or from when you started your first treatment) are available **You may NOT be eligible if...** - You have any health conditions listed as warnings or contraindications on the upadacitinib or risankizumab labels - You have previously been treated with upadacitinib, risankizumab, or any other biologic medication for Crohn's disease (other than TNF-blockers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Locations(23)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07073079

Related Trials

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

NCT0592307385 locations

A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)

NCT072422481 location

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

NCT06233461193 locations

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT0544256798 locations

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

NCT0610028957 locations