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 (CROHNOS)

AbbVie

Status: Enrolling

Conditions: Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT07073079

P25-397

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

Upadacitinib

Description:

Participants with Crohn's Disease prescribed upadacitinib in routine clinical practice are observed from the first dose up to 18 months.

Risankizumab

Description:

Participants with Crohn's Disease prescribed risankizumab in routine clinical practice are observed from the first dose up to 18 months.