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Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

2018年3月12日 更新者：Pfizer

Phase 1, Randomized, Patient And Investigator-blind, Placebo-controlled Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of Pf-04236921 In Patients With Rheumatoid Arthritis Receiving Methotrexate

This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Blood tests will be performed to measure the amount of drug and changes in measures of inflammation.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.

研究类型

介入性

注册 (实际的)

41

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 大韩民国
      • Incheon、大韩民国、400-711
        • Inha University Hospital, Medicine/Rheumatology
      • Seoul、大韩民国、110-744
        • Seoul National University Hospital, Rheumatology, Internal Medicine
      • Seoul、大韩民国、120-752
        • Yonsei University College of Medicine, Severance Hospital, Clinical Trial Center
  • 美国
    • Florida
      • Daytona Beach、Florida、美国、32114
        • Allergy, Asthma, Arthritis, & Lung
      • Ormond Beach、Florida、美国、32174
        • Millennium Research
    • Pennsylvania
      • Duncansville、Pennsylvania、美国、16635
        • Altoona Center for Clinical Research
  • 西班牙
      • A Coruña、西班牙、15006
        • Complexo Hospitalario Universitario A Coruña
    • A Coruña
      • Santiago de Compostela、A Coruña、西班牙、15706
        • Hospital Clínico Universitario de Santiago

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Rheumatoid Arthritis on a stable dose of methotrexate
  • Rheumatoid Arthritis disease activity as assessed by blood tests

Exclusion Criteria:

  • Serious or uncontrolled medical conditions
  • Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab
  • Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：Placebo
intravenous infusion on three consecutive months
实验性的：PF-04236921
药品：dose level 1
intravenous infusion on three consecutive months
药品：dose level 2
intravenous infusion on three consecutive months
药品：dose level 3
intravenous infusion on three consecutive months
药品：dose level 4
intravenous infusion on 3 consecutive months

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)
Number of Participants With Positive Anti-drug Antibodies Response
大体时间：Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
Maximum Observed Serum Concentration (Cmax): Day 1
大体时间：Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1
大体时间：Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1
大体时间：Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Maximum Observed Serum Concentration (Cmax): Day 28
大体时间：Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28
大体时间：Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28
大体时间：Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Maximum Observed Serum Concentration (Cmax): Day 56
大体时间：Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56
大体时间：Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56
大体时间：Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Serum Decay Half-Life (t1/2): Day 56
大体时间：Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

其他结果措施

结果测量
措施说明
大体时间
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation
大体时间：Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra sensitive assay. A decrease in the level of CRP indicates reduction in inflammation.
Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
Change From Baseline in Log CRP Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
大体时间：Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation
大体时间：Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624
大体时间：Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
Serum samples were analyzed for IL-6 concentrations using a validated analytical colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) method.
Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2009年5月20日

初级完成 (实际的)

2012年2月2日

研究完成 (实际的)

2012年2月2日

研究注册日期

首次提交

2009年2月4日

首先提交符合 QC 标准的

2009年2月4日

首次发布 (估计)

2009年2月6日

研究记录更新

最后更新发布 (实际的)

2018年11月2日

上次提交的符合 QC 标准的更新

2018年3月12日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • B0151002
  • 2009-009866-15 (EudraCT编号)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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