临床试验/NCT02889796

NCT02889796已完成3 期

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Gilead Sciences0 个研究点目标入组 1,759 人开始时间: 2016年8月30日最近更新: 2021年6月9日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Gilead Sciences
入组人数: 1,759
主要终点: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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 rheumatoid arthritis (RA) [2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria] , 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 both screening and Day
•Ongoing treatment with a stable dose of MTX

排除标准

•Previous treatment with any janus kinase (JAK) inhibitor
•NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

研究组 & 干预措施

Filgotinib 200 mg

Experimental

Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)

干预措施: Filgotinib (Drug)

Filgotinib 200 mg

Experimental

Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)

干预措施: Placebo to match filgotinib (Drug)

Filgotinib 200 mg

Experimental

Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)

干预措施: Placebo to match adalimumab (Drug)

Filgotinib 200 mg

Experimental

Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)

干预措施: MTX (Drug)

Filgotinib 100 mg

Experimental

Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX

干预措施: Filgotinib (Drug)

Filgotinib 100 mg

Experimental

Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX

干预措施: Placebo to match filgotinib (Drug)

Filgotinib 100 mg

Experimental

Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX

干预措施: Placebo to match adalimumab (Drug)

Filgotinib 100 mg

Experimental

Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX

干预措施: MTX (Drug)

Adalimumab

Active Comparator

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX

干预措施: Placebo to match filgotinib (Drug)

Adalimumab

Active Comparator

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX

干预措施: Adalimumab (Drug)

Adalimumab

Active Comparator

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX

干预措施: MTX (Drug)

Placebo to Filgotinib 200 mg

Experimental

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 200 mg to receive filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

干预措施: Filgotinib (Drug)

Placebo to Filgotinib 200 mg

Experimental

干预措施: Placebo to match filgotinib (Drug)

Placebo to Filgotinib 200 mg

Experimental

干预措施: Placebo to match adalimumab (Drug)

Placebo to Filgotinib 200 mg

Experimental

干预措施: MTX (Drug)

Placebo to Filgotinib 100 mg

Experimental

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

干预措施: Filgotinib (Drug)

Placebo to Filgotinib 100 mg

Experimental

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

干预措施: Placebo to match filgotinib (Drug)

Placebo to Filgotinib 100 mg

Experimental

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

干预措施: Placebo to match adalimumab (Drug)

Placebo to Filgotinib 100 mg

Experimental

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.

干预措施: MTX (Drug)

Placebo Never Received Filgotinib

Placebo Comparator

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.

干预措施: Placebo to match filgotinib (Drug)

Placebo Never Received Filgotinib

Placebo Comparator

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.

干预措施: Placebo to match adalimumab (Drug)

Placebo Never Received Filgotinib

Placebo Comparator

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.

干预措施: MTX (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)participant'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 the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12(Baseline; Week 12)
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24(Baseline; Week 24)
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12(Week 12)
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12(Week 12)
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 ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24(Weeks 2, 4, 12, and 24)
Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52(Weeks 36, and 52)
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24(Weeks 2, 4, 12, and 24)
Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52(Weeks 36, and 52)
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24(Weeks 2, 4, and 24)
Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52(Weeks 36, and 52)
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24(Baseline; Weeks 2, 4, and 24)
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24(Weeks 2, 4, 12, and 24)
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52(Weeks 36, and 52)
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in DAS28 (CRP) at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24(Weeks 2, 4, and 24)
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52(Weeks 36, and 52)
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24(Weeks 2, 4, and 24)
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52(Weeks 36, and 52)
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24(Weeks 2, 4, 12, and 24)
ACR N Percent Improvement (ACR-N) at Weeks 36, and 52(Weeks 36, and 52)
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24(Weeks 2, 4, 12, and 24)
Number of Participants With EULAR Response at Weeks 36, and 52(Weeks 36, and 52)
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in CDAI at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24(Baseline; Weeks 2, 4, 12, and 24)
Change From Baseline in SDAI at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in mTSS at Week 52(Baseline; Week 52)
Percentage of Participants With no Radiographic Progression From Baseline at Week 24(Baseline; Weeks 24)
Percentage of Participants With no Radiographic Progression From Baseline at Week 52(Baseline; Week 52)
36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
SF-36 PCS Score at Weeks 36, and 52(Weeks 36, and 52)
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24(Baseline; Weeks 4, and 24)
Change From Baseline in SF-36 PCS Score at Weeks 36, and 52(Baseline; Weeks 36, and 52)
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
SF-36 MCS Score at Weeks 36, and 52(Weeks 36, and 52)
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24(Baseline; Weeks 4, 12, and 24)
Change From Baseline in SF-36 MCS Score at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
FACIT-Fatigue Score at Weeks 36, and 52(Weeks 36, and 52)
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24(Baseline; Weeks 4, and 24)
Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52(Baseline; Weeks 36, and 52)
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)
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52(Weeks 36, and 52)
EQ-5D Current Health VAS at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
EQ-5D Current Health VAS at Weeks 36, and 52(Weeks 36, and 52)
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 EQ-5D Current Health VAS at Weeks 36, and 52(Baseline; Weeks 36, and 52)
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)
WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52(Weeks 36, and 52)
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 Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52(Weeks 36, and 52)
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA 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 36, and 52(Weeks 36, and 52)
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24(Weeks 4, 12, and 24)
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52(Weeks 36, and 52)
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 Work Time Missed (Absenteeism) at Weeks 36, and 52(Baseline; Weeks 36, and 52)
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 Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52(Baseline; Weeks 36, and 52)
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)
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)
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52(Baseline; Weeks 36, and 52)
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52(Baseline; Weeks 36, and 52)

研究者

发起方

Gilead Sciences

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

3 期

Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) TreatmentRheumatoid Arthritis

NCT02873936Gilead Sciences449

终止

3 期

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD TherapyPsoriatic Arthritis

NCT04115748Gilead Sciences67

终止

2 期

Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious UveitisNoninfectious Uveitis

NCT03207815Gilead Sciences74

终止

3 期

Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD TherapyPsoriatic Arthritis

NCT04115839Gilead Sciences106

已完成

2 期

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's DiseaseFistulizing Crohn's Disease

NCT03077412Gilead Sciences57