Crohn'sRecruiting
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
Observational · No treatment assigned · 25 sites · AbbVie
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 250 participants are expected to take part.
- Start date: 2025-07-14.
- Main results expected around 2027-12 (estimate from the record).
- 25 study sites listed (25 marked recruiting) in Italy.
Main thing being measured
- Percentage of Participants who Achieve Corticosteroids (CS) Free Remission (Month 12)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn's Disease |
| Lead sponsor | AbbVie |
| Enrollment | 250 (estimated) |
| Start date | 2025-07-14 |
| Primary completion (est.) | 2027-12 |
| First posted | 2025-07-18 |
| Last updated | 2026-06-24 |
| 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) |
| ClinicalTrials.gov ID | NCT07073079 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (25)
| Site | City | Country | Site status |
|---|---|---|---|
| A.O.U. Consorziale Policlinico di Bari /ID# 274662 | Bari | Italy | Recruiting |
| IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161 | Bologna | Italy | Recruiting |
| Azienda Ospedaliera G. Brotzu /ID# 275125 | Cagliari | Italy | Recruiting |
| AOU Policlinico G. Rodolico - San Marco /ID# 274909 | Catania | Italy | Recruiting |
| Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571 | Catanzaro | Italy | Recruiting |
| Ospedale San Martino /ID# 274529 | Genova | Italy | Recruiting |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618 | Milan | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964 | Palermo | Italy | Recruiting |
| Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460 | Pescara | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488 | Roma | Italy | Recruiting |
| Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966 | Roma | Italy | Recruiting |
| 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 |
| Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570 | Naples, Napoli | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788 | Naples, Napoli | Italy | Recruiting |
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461 | Turin, Piedmont | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654 | Rome, Roma | Italy | Recruiting |
| Ospedale Sandro Pertini /ID# 275023 | Rome, Roma | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530 | Rome, Roma | Italy | Recruiting |
| A.O. Ordine Mauriziano di Torino /ID# 274459 | Turin, Torino | Italy | Recruiting |
| IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462 | Negrar, Verona | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.