Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 250
- Locations
- 41
- Primary Endpoint
- Percentage of Participants who Achieve Corticosteroids (CS) Free Remission
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Upadacitinib
Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months.
Risankizumab
Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months.
Outcomes
Primary Outcomes
Percentage of Participants who Achieve Corticosteroids (CS) Free Remission
Time Frame: Month 12
CS free remission is defined as clinical remission with Harvey Bradshaw Index (HBI) \<4 and absence of corticosteroid use since at least three months prior to month 12.
Secondary Outcomes
No secondary outcomes reported