Multicenter Registry Study on the Efficacy and Safety of Anti-IL-23p19 Antibodies for Ulcerative Colitis

UMIN ID: UMIN000055475

Registered date:11/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 2024/04/05
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Clinical remission at 4 weeks, 12 weeks, 28 weeks, and 52 weeks after initiation of treatment
• Secondary Outcome: Rates of clinical improvement, achievement of steroid-free remission, changes in quality of life (QOL), rates of biomarker remission, and incidence of adverse events at 4 weeks, 12 weeks, 28 weeks, and 52 weeks after treatment initiation Rate of endoscopic remission at 52 weeks Analysis of factors contributing to successful induction and maintenance of remission

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Individuals who do not consent to the purpose of this observational study. Cases where the attending physician determines that participation in the research is inappropriate.

Related Information

• Primary Sponsor: Saga University
• Source(s) of Monetary Support: Saga University