Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)
Status: Recruiting
Location: See all (21) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
A.O.U. Consorziale Policlinico di Bari /ID# 274662
RECRUITING
Bari
Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706
RECRUITING
Castellana Grotte
AOU Policlinico G. Rodolico - San Marco /ID# 274909
RECRUITING
Catania
Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571
RECRUITING
Catanzaro
Ospedale San Martino /ID# 274529
NOT_YET_RECRUITING
Genoa
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 274618