NCT07073079Recruiting
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)
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 2 Jun 2025
- Start date
- 14 Jul 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- AbbVie
- Diseases
- Crohn's disease
- NCT number
- NCT07073079
What you commit to
- Study type: Observational
- Planned participants: 250
- From 14 Jul 2025 to the primary completion date, Dec 2027
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD
Other illness
- Any condition included in the "warning and precautions" and "contraindications" section of the approved local upadacitinib/risankizumab label
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| A.O.U. Consorziale Policlinico di Bari /ID# 274662 Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161 Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliera G. Brotzu /ID# 275125 Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706 Coordinator of this site? Confirm its status | Castellana Grotte | Italy | Recruiting |
| AOU Policlinico G. Rodolico - San Marco /ID# 274909 Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571 Coordinator of this site? Confirm its status | Catanzaro | Italy | Recruiting |
| Ospedale San Martino /ID# 274529 Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| IRCCS Ospedale San Raffaele /ID# 274458 Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618 Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216 Coordinator of this site? Confirm its status | Monserrato | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682 Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570 Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788 Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462 Coordinator of this site? Confirm its status | Negrar | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964 Coordinator of this site? Confirm its status | Palermo | Italy | Recruiting |
| Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460 Coordinator of this site? Confirm its status | Pescara | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488 Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966 Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Ospedale Sandro Pertini /ID# 275023 Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654 Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530 Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| IRCCS Istituto Clinico Humanitas /ID# 274489 Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669 Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| A.O. Ordine Mauriziano di Torino /ID# 274459 Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461 Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.