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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 41
- 试验地点
- 8
- 主要终点
- Number of Participants With Positive Anti-drug Antibodies Response
研究概览
简要总结
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.
详细描述
Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid Arthritis on a stable dose of methotrexate
- •Rheumatoid Arthritis disease activity as assessed by blood tests
排除标准
- •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
研究组 & 干预措施
PF-04236921
干预措施: dose level 4 (Drug)
PF-04236921
干预措施: dose level 3 (Drug)
Placebo
干预措施: Placebo (Drug)
PF-04236921
干预措施: dose level 1 (Drug)
PF-04236921
干预措施: dose level 2 (Drug)
结局指标
主要结局
Number of Participants With Positive Anti-drug Antibodies Response
时间窗: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
Maximum Observed Serum Concentration (Cmax): Day 28
时间窗: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Maximum Observed Serum Concentration (Cmax): Day 56
时间窗: 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
时间窗: 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).
Maximum Observed Serum Concentration (Cmax): Day 1
时间窗: 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
时间窗: 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).
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28
时间窗: 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
时间窗: 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).
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 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.
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56
时间窗: 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 1
时间窗: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Serum Decay Half-Life (t1/2): Day 56
时间窗: 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.
次要结局
未报告次要终点