NCT05791526

An Observational Study to Assess Change in Disease Activity and Adverse Events of Rinvoq in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Japan

A Prospective Observational Study for Evaluation of Safety and Effectiveness of Rinvoq in Moderately to Severely Active Ulcerative Colitis; a Japanese Post-Marketing Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 308 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective Rinvoq is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Rinvoq is a drug approved for the treatment of ulcerative colitis (UC). All study participants will receive Rinvoq as prescribed by their study doctor in accordance with approved local label. Approximately 300 adult 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 60 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Conditions

• Ulcerative Colitis

Timeline

• Start date: 2022-12-19
• Primary completion: 2025-12-09
• Completion: 2025-12-09
• First posted: 2023-03-30
• Last updated: 2025-12-31

Locations

114 sites across 1 country: Japan