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ID06246123

Safety and Effectiveness Study of Jyseleca Filgotinib Maleate Tablets in Korean Adults with Rheumatoid Arthritis or Ulcerative Colitis

Led by Eisai Korea Inc. · Updated on 2026-07-06

2040

Participants Needed

59

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to collect and evaluate safety and effectiveness information about Jyseleca tablet Filgotinib Maleate 100 mg and 200 mg in Korean participants using it in real-world conditions. The study focuses on monitoring serious and non-serious adverse events and drug reactions, including unexpected ones, as well as changes in disease activity scores related to rheumatoid arthritis and ulcerative colitis. Participants prescribed Jyseleca according to Korean approved therapeutic indications will be observed without additional intervention. They will be followed for up to 24 weeks or until they stop treatment due to adverse events or other reasons. The study includes adults with rheumatoid arthritis or ulcerative colitis who have not responded well or are intolerant to prior treatments. During the study, researchers will track adverse events and reactions from enrollment through 24 weeks. They will also measure changes in disease activity scores at baseline, week 12, and week 24. Participants will have regular monitoring visits as part of their usual care, with data collected about safety and treatment effects. The total participation time is up to 24 weeks.

CONDITIONS

Brief Title

A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants

Research Team

S

Serena SoYoun Kwon

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