NCT06625242已完成4 期
A Multicenter, Open-label, Single-arm, Phase 4 Study to Evaluate the Efficacy and Safety of Filgotinib in Korean Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 15
- 主要终点
- Percentage of Participants Achieving ACR20 Response at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •DAS28 score between 3.2 and 5.1, with diagnostic imaging showing progression of joint damage.
排除标准
- •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
研究组 & 干预措施
Filgotinib Maleate 100 or 200 milligram
Experimental
干预措施: Filgotinib Maleate (Drug)
结局指标
主要结局
Percentage of Participants Achieving ACR20 Response at Week 12
时间窗: At Week 12
次要结局
- 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)
- Percentage of Participants Achieving an ACR50 and ACR70 Responses at Weeks 12 and 24(At Weeks 12 and 24)
- Percentage of Participants Achieving an ACR20, ACR50 and ACR70 Responses at Week 12 and Week 24 Depending on the Prior Treatment Therapy(At Weeks 12 and 24)
- Percentage of Participants Achieving an ACR20, ACR50 and ACR70 Responses at Weeks 12 and 24 Depending on Monotherapy With the Investigational Product and Combination Therapy With Methotrexate (MTX)(At Weeks 12 and 24)
- Percentage of Participants Achieving an ACR20 Response at Week 12 Depending on Demographic Characteristics(At Weeks 12)
- Number of Participants With Adverse Events (AEs)(Baseline up to 28 weeks)
研究者
研究点 (15)
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