Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
A.O.U. Consorziale Policlinico di Bari /ID# 274662
Coordinator of this site? Confirm its status
BariItalyRecruiting
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Azienda Ospedaliera G. Brotzu /ID# 275125
Coordinator of this site? Confirm its status
CagliariItalyRecruiting
Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706
Coordinator of this site? Confirm its status
Castellana GrotteItalyRecruiting
AOU Policlinico G. Rodolico - San Marco /ID# 274909
Coordinator of this site? Confirm its status
CataniaItalyRecruiting
Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571
Coordinator of this site? Confirm its status
CatanzaroItalyRecruiting
Ospedale San Martino /ID# 274529
Coordinator of this site? Confirm its status
GenovaItalyRecruiting
IRCCS Ospedale San Raffaele /ID# 274458
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216
Coordinator of this site? Confirm its status
MonserratoItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682
Coordinator of this site? Confirm its status
MonzaItalyRecruiting
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462
Coordinator of this site? Confirm its status
NegrarItalyRecruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964
Coordinator of this site? Confirm its status
PalermoItalyRecruiting
Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460
Coordinator of this site? Confirm its status
PescaraItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488
Coordinator of this site? Confirm its status
RomaItalyRecruiting
Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966
Coordinator of this site? Confirm its status
RomaItalyRecruiting
Ospedale Sandro Pertini /ID# 275023
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530
Coordinator of this site? Confirm its status
RomeItalyRecruiting
IRCCS Istituto Clinico Humanitas /ID# 274489
Coordinator of this site? Confirm its status
RozzanoItalyRecruiting
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669
Coordinator of this site? Confirm its status
San Giovanni RotondoItalyRecruiting
A.O. Ordine Mauriziano di Torino /ID# 274459
Coordinator of this site? Confirm its status
TurinItalyRecruiting
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461
Coordinator of this site? Confirm its status
TurinItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.