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临床试验/NCT02480153
NCT02480153已完成3 期

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Pfizer362 个研究点 分布在 2 个国家目标入组 597 人开始时间: 2015年6月25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
597
试验地点
362
主要终点
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: 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, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.

In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

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 8 mg/L.
  • •Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.

排除标准

  • •Evidence of untreated or inadequately treated latent or active TB.
  • •Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
  • •History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
  • •May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
  • •Any second DMARD must be washed out prior to the first study dose.

研究组 & 干预措施

Adalimumab

Active Comparator

干预措施: Adalimumab (Biological)

PF-06410293

Experimental

干预措施: PF-06410293 (Biological)

结局指标

主要结局

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1

时间窗: Week 12

ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).

次要结局

  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1(Weeks 2, 4, 6, 8, 18 and 26 (pre-dose))
  • Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1(Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2(Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Change From Baseline in Tender Joint Count: Period 2(Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3(Weeks 52, 56, 66, 76 and 78)
  • Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1(Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3(Weeks 52, 56, 66, 76 and 78)
  • Change From Baseline in Tender Joint Count: Period 3(Baseline, Weeks 52, 56, 66, 76 and 78)
  • Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2(Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Change From Baseline in Swollen Joint Count: Period 3(Baseline, Weeks 52, 56, 66, 76 and 78)
  • Change From Baseline in Swollen Joint Count: Period 1(Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2(Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1(Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2(Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Change From Baseline in Swollen Joint Count: Period 2(Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2(Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3(Weeks 52, 56, 66, 76 and 78)
  • Change From Baseline in Tender Joint Count: Period 1(Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2(Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3(Baseline, Weeks 52, 56, 66, 76 and 78)
  • Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3(Baseline, Weeks 52, 56, 66, 76 and 78)
  • Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2(Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1(Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1(Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1(Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2(Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1(Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1(Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3(Baseline, Weeks 52, 56, 66, 76 and 78)
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2(Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3(Baseline, Weeks 52, 56, 66, 76 and 78)
  • Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2(Week 26 dosing up to Week 52 (pre-dose))
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3(Baseline, Weeks 52, 56, 66, 76 and 78)
  • Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3(Baseline, Weeks 52, 56, 66, 76 and 78)
  • Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2(Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3(Weeks 52, 56, 66, 76 and 78)
  • Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2(Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Serum Concentration Versus Time Summary: Period 1(Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit)
  • Serum Concentration Versus Time Summary: Period 2(Pre-dose on Days 183, 211, 253 and 365)
  • Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1(Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1(Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1(Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose))
  • Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3(Weeks 52, 56, 66, 76 and 78)
  • Number of Participants With Laboratory Abnormalities: Period 2(Week 26 dosing up to Week 52 (pre-dose))
  • Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2(Weeks 26, 30, 36, 44 and 52 (pre-dose))
  • Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3(Weeks 52, 56, 66, 76 and 78)
  • Serum Concentration Versus Time Summary: Period 3(Pre-dose on Days 365, 393, 463, 547 and 575)
  • Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1(Baseline up to Week 26 (pre-dose))
  • Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3(Week 52 dosing up to follow-up visit (Week 92))
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3(Week 52 dosing up to follow-up visit (Week 92))
  • Number of Participants With Laboratory Abnormalities: Period 1(Baseline (Day 1) up to Week 26 (pre-dose))
  • Number of Participants With Laboratory Abnormalities: Period 3(Week 52 dosing up to follow-up visit (Week 92))
  • 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 26 (pre-dose))
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2(Week 26 dosing up to Week 52 (pre-dose))

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (362)

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