NCT06023030

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

A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• 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 upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 participants will be enrolled in Japan. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 64 weeks. 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: 2023-07-28
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2023-09-05
• Last updated: 2026-02-24

Locations

104 sites across 1 country: Japan