NCT05841537

An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)

A Prospective, Post-marketing, Non-interventional Study of RISankizumab Evaluating Real-world Clinical Effectiveness in Crohn's Disease (APPRISE)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,019 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Conditions

• Crohn's Disease

Timeline

• Start date: 2023-06-09
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2023-05-03
• Last updated: 2025-05-09

Locations

154 sites across 11 countries: Austria, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, United Arab Emirates