A Study of Filgotinib in Korean Participants With Rheumatoid Arthritis

NCT06625242 | Active Not Recruiting Phase 4

• 1 other identifier: GS6034-M082-401
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Filgotinib Maleate

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving ACR20 Response at Week 12

  At Week 12

Secondary Outcomes (10)

• Percentage of Participants Achieving Disease Activity Score for 28 (DAS28) C-reactive Protein (CRP) Less Than or Equal to (<=) 3.2 at Weeks 12 and 24

  At Weeks 12 and 24

• Change From Baseline in DAS28 (CRP) at Weeks 12 and 24

  Baseline, Weeks 12 and 24

• Percentage of Participants Achieving DAS28 (CRP) Less Than (<) 2.6 at Weeks 12 and 24

  At Weeks 12 and 24

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24

  Baseline, Weeks 12 and 24

• Percentage of Participants Achieving an ACR20 Response at Week 24

  At Week 24

Study Arms (1)

Filgotinib Maleate 100 or 200 milligram

EXPERIMENTAL

Drug: Filgotinib Maleate

Interventions

Filgotinib Maleate DRUG

Administered as oral tablets.

Also known as: Jyseleca

Filgotinib Maleate 100 or 200 milligram

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Furthermore, in participants over 65 years of age, those at high risk of cardiovascular diseases, and those with a potential risk of malignancy, this protocol applies if they have not adequately responded to or tolerated conventional therapies, including Tumor Necrosis Factor (TNF) inhibitors or other biologic agents. Eligibility is confirmed if one of the following criteria is met:
• DAS28 score exceeding 5.1.
• DAS28 score between 3.2 and 5.1, with diagnostic imaging showing progression of joint damage.

You may not qualify if:

• 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)
• Participants with severe hepatic impairment (e.g., Child-Pugh C)
• Participants with end-stage renal disease (\<creatinine clearance \[CrCl\] 15 milliliters per minute \[mL/min\])
• Participants with absolute neutrophil count (ANC) \<1\*10\^9 cells per liter (/L)
• Participants with absolute lymphocyte count (ALC) \<0.5\*10\^9 cells/L
• Participants with hemoglobin \<8 grams per deciliter (g/dL)
• Pregnant or lactating women
• Women of childbearing potential who are not willing to consent to using effective contraception
• Participants with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product
• Participants who received Janus kinase (JAK) inhibitors for the treatment of rheumatoid arthritis
• Participants who have participated in other clinical studies for investigational product/medical device within 4 weeks prior to screening
• Participants in whom the administration of Jyseleca Tablet is contraindicated according to the product label approved in Korea or based on certain medical conditions that have been identified in previous clinical studies
• Participants for whom follow-up deems impossible

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (15)

Eisai site #11

Anyang-si, South Korea

Location

Eisai site #01

Busan, South Korea

Location

Eisai site #09

Daegu, South Korea

Location

Eisai site #12

Daegu, South Korea

Location

Eisai site #06

Daejeon, South Korea

Location

Eisai site #15

Guri-si, South Korea

Location

Eisai site #02

Gwangju, South Korea

Location

Eisai site #13

Incheon, South Korea

Location

Eisai site #03

Seoul, South Korea

Location

Eisai site #04

Seoul, South Korea

Location

Eisai site #05

Seoul, South Korea

Location

Eisai site #07

Seoul, South Korea

Location

Eisai site #08

Seoul, South Korea

Location

Eisai site #10

Seoul, South Korea

Location

Eisai site #14

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 3, 2024
• Study Start: October 22, 2024
• Primary Completion: February 26, 2026
• Study Completion: March 19, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (15)