A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 449
- 主要终点
- Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
研究概览
简要总结
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League Against Rheumatism [EULAR] criteria for RA), and are ACR functional class I-III.
- •Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints [SJC66]) and ≥6 tender joints (from a tender joint count based on 68 joints [TJC68]) at screening and Day 1
- •Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
- •Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance
排除标准
- •Previous treatment with any janus kinase (JAK) inhibitor
- •NOTE: Other protocol Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Filgotinib 200 mg
Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)
干预措施: Filgotinib (Drug)
Filgotinib 200 mg
Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)
干预措施: Placebo to match filgotinib (Drug)
Filgotinib 200 mg
Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)
干预措施: csDMARDs (Drug)
Filgotinib 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)
干预措施: Filgotinib (Drug)
Filgotinib 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)
干预措施: Placebo to match filgotinib (Drug)
Filgotinib 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)
干预措施: csDMARDs (Drug)
Placebo
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)
干预措施: Placebo to match filgotinib (Drug)
Placebo
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)
干预措施: csDMARDs (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
时间窗: Week 12
ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 \[0 and 100 indicating no disease activity and maximum disease activity\]; subject's pain assessment using VAS on a scale of 0-100 \[0 and 100 indicating no pain and unbearable pain\]; health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 \[0 and 3 indicating without difficulty and unable to do\]; high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
次要结局
- Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12(Baseline; Week 12)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12(Baseline; Week 12)
- Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24(Weeks 4, and 24)
- Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12(Week 12)
- Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12(Baseline; Week 12)
- Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24(Week 24)
- Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24(Baseline; Weeks 4, and 24)
- Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 24(Weeks 4, and 24)
- Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12(Weeks 4, and 12)
- Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24(Baseline; Weeks 4, and 24)
- Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- SF-36 PCS Score at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Change From Baseline in SF-36 PCS Score at Weeks 4, and 24(Baseline; Weeks 4, and 24)
- SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- FACIT-Fatigue Score at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
- Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- EQ-5D Current Health VAS at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
- Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)