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临床试验/NCT02222493
NCT02222493已完成3 期

A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

Pfizer366 个研究点 分布在 3 个国家目标入组 650 人开始时间: 2014年8月26日最近更新:
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适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
650
试验地点
366
主要终点
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
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研究点记录与标识符相似试验

研究概览

简要总结

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • •Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
  • •At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
  • •HS-CRP equal or greater than 10 mg/L.
  • •Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.

排除标准

  • •Evidence of untreated or inadequately treated latent or active TB.
  • •Evidence or history of moderate or severe heart failure (NYHA Class III/IV)
  • •Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.

研究组 & 干预措施

PF-06438179

Experimental

干预措施: PF-06438179 (Biological)

Infliximab

Active Comparator

干预措施: Infliximab (Biological)

结局指标

主要结局

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1

时间窗: Week 14

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index \[HAQ-DI\]); and C-Reactive Protein (CRP).

次要结局

  • Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3(Week 62, 70 and 78)
  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1(Week 2, 4, 6, 12, 22 and 30 (pre-dose))
  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2(Week 38, 46 and 54 (pre-dose))
  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3(Week 62, 70 and 78)
  • Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1(Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose))
  • Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2(Week 38, 46 and 54 (pre-dose))
  • Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3(Baseline (Week 54 pre-dose), Week 62, 70 and 78)
  • Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1(Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose))
  • Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1(Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30)
  • Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2(Baseline (Week 30 pre-dose), Week 38, 46 and 54)
  • Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2(Week 38, 46 and 54 (pre-dose))
  • Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3(Week 62, 70 and 78)
  • Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1(Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose))
  • Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2(Week 38, 46 and Week 54 (pre-dose))
  • Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3(Week 62, 70 and Week 78)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1(Baseline (Day 1) up to Week 30)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2(Baseline (Week 30 pre-dose) up to Week 54)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3(Baseline (Week 54 pre-dose) up to Week 78)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1(Baseline (Day 1) up to Week 30)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2(Baseline (Week 30 pre-dose) up to Week 54)
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3(Baseline (Week 54 pre-dose) up to Week 78)
  • Number of Participants With Laboratory Abnormalities: Period 1(Baseline (Day 1) up to Week 30)
  • Number of Participants With Laboratory Abnormalities: Period 2(Baseline (Week 30 pre-dose) up to Week 54)
  • Number of Participants With Laboratory Abnormalities: Period 3(Baseline (Week 54 pre-dose) up to Week 78)
  • Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1(Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30)
  • Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2(Baseline (Week 30 pre-dose), Week 38, 46 and Week 54)
  • Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3(Baseline (Week 54 pre-dose), Week 62, 70 and 78)
  • Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2(Baseline (Week 30 pre-dose), Week 38, 46 and 54)
  • Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3(Baseline (Week 54 pre-dose), Week 62, 70 and 78)
  • Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1(Baseline (Day 1) up to Week 30)
  • Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2(Baseline (Week 30 pre-dose) up to Week 54)
  • Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3(Baseline (Week 54 pre-dose) up to Week 78)
  • Serum Concentration Versus Time Summary: Period 1(Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29)
  • Serum Concentration Versus Time Summary: Period 2(Pre dose on Day 211, 267, 379 and 547)
  • Serum Concentration Versus Time Summary: Period 3(Pre dose on Day 379, 435 and 547)
  • Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1(Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30)
  • Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2(Baseline (Week 30 pre-dose), Week 38, 46 and 54)
  • Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3(Baseline (Week 54 pre-dose), Week 62, 70 and 78)
  • Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1(Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (366)

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