A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis (NCT06625242) | Clinical Trial Compass
CompletedPhase 4
A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis
South Korea118 participantsStarted 2024-10-22
Plain-language summary
The primary purpose of this study is to assess the percentage of participants achieving an American College of Rheumatology (ACR) 20 percent (%) Improvement (ACR20) response at Week 12 of the administration of the investigational product.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Participants who voluntarily provided written consent to participate in this study
✓. Male or female, aged greater than or equal to (\>=) 19 years at the time of written informed consent
✓. Participants diagnosed with rheumatoid arthritis according to the 2010 ACR/ European League Against Rheumatism (EULAR) classification criteria and who have an ACR functional class of I to III
✓. Participants who meet the following criteria are eligible for the specified treatment protocol; those who have been treated with two or more type types (including MTX) of Disease-Modifying Antirheumatic Drugs (DMARDs) for at least 6 months (at least 3 months each) but have experienced insufficient therapeutic effects or have had to discontinue treatment due to adverse events of these medications (However, in cases where MTX is contraindicated due to conditions such as liver disease or renal failure, the participant must have been treated with at least two types of DMARDs, excluding MTX).
✓. DAS28 score exceeding 5.1.
✓. DAS28 score between 3.2 and 5.1, with diagnostic imaging showing progression of joint damage.
Exclusion criteria
✕. Participants with hypersensitivity reactions to the active ingredient or other components of the investigational product
✕. Participants with serious infections (for example \[e.g.\], sepsis) or active infections including localized infections
✕. Participants with active tuberculosis (TB)
✕
What they're measuring
1
Percentage of Participants Achieving ACR20 Response at Week 12