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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbVie

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • Not listed

Trial groups

250 Participants
are grouped into 2 trial groups

Sponsors and collaborators