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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Detailed description
The retrospective phase will be up to 2 years prior to enrollment to the study, the prospective phase will be up to 18 months after enrollment.
Primary outcome measures
- Percentage of Participants who Achieve Corticosteroids (CS) Free Remission [Time frame: Month 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 25 centers
- Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706 — Castellana Grotte
- Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216 — Monserrato
- Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669 — San Giovanni Rotondo
- IRCCS Istituto Clinico Humanitas /ID# 274489 — Rozzano
- IRCCS Ospedale San Raffaele /ID# 274458 — Milan
- Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682 — Monza
- Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570 — Naples
- Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788 — Naples
- … and 17 more centers
Identifiers
NCT: NCT07073079 · P25-397