NCT00620685已完成2 期
A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings
研究概览
简要总结
The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of 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
- Triple (Participant, Care Provider, 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
- •Adult with RA for at least 6 months
- •Stable weekly dosage of oral methotrexate 12.5- 25 mg/week
排除标准
- •Severe, progressive and/or uncontrolled other disease
- •Chronic or recent serious infection; current infection
- •Concomitant use of RA therapy other than methotrexate with some exceptions
研究组 & 干预措施
1
Placebo Comparator
干预措施: Placebo (Drug)
2
Experimental
干预措施: PH-797804 (Drug)
3
Experimental
干预措施: PH-797804 (Drug)
结局指标
主要结局
Adverse events, laboratory data, vital signs, 12-lead ECGs and physical examination findings
时间窗: 6 weeks
次要结局
- Estimate the effects of multiple doses of PH-797804 on the pharmacokinetic profile of methotrexate in subjects with RA taking a stable dose of MTX(6 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate TherapyRheumatoid ArthritisNCT00316771Hoffmann-La Roche374
已完成
2 期
An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid ArthritisArthritis, RheumatoidNCT00383188Pfizer305
已完成
2 期
A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not HospitalizedSARS-CoV-2 InfectionNCT05799495Pfizer240
已完成
1 期
Study In Healthy Adult Volunteers To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429HealthyNCT01117233Pfizer40
已完成
2 期
A Clinical Study of Two Doses of a Selective p38 MAP Kinase Inhibitor, VX-745, to Evaluate the Effects of 12-Week Oral Twice-Daily Dosing on Amyloid Plaque Load as Assessed by Quantitative Dynamic 11C-PiB Positive Emission Tomography (PET) Amyloid Scanning1005716710012272Alzheimer's diseasedementiaNL-OMON44613EIP Pharma, LLC16