NCT00419809已完成1 期
A Placebo Controlled Study to Evaluate the Safety and Tolerability of Repeat Doses of SB-681323 in Patients Receiving Methotrexate for Rheumatoid Arthritis.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- The primary outcome measure is the values of liver function tests following dosing with methotrexate alone (Day 1) and methotrexate and SB-681323 or placebo (Day 15).
研究概览
简要总结
SB-681323 is a p38 MAP-kinase inhibitor that has potential uses in inflammatory conditions such as RA. Previous p38 MAP-kinase inhibitors have been hindered in development by liver toxicity. Methotrexate (common treatment for RA patients) also has potential liver toxicity. This study was an enabling study to determine the safety of co-administration of the two compounds with respect to liver function
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female. Females must be of non-child-bearing capacity
- •BMI 19 - 30 kg/m2 (inclusive)
- •Diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR)
- •Negative urine drugs of abuse screen, breath alcohol tests, hepatitis B and C, and HIV tests.
- •Liver function tests within normal limits
- •Must be on a stable dose of methotrexate (2.5 - 25 mg/week) for >8 weeks prior to enrolment and which will not be changed during the course of this study.
- •Must be on stable folate supplements for >8 weeks prior to enrolment with normal red cell folate levels at enrollment.
排除标准
- •History of alcohol &/or drug abuse
- •Abnormal ECGs at screening
- •Liver disease, uncontrolled hypertension, diabetes mellitus, psoriasis, history of peptic ulcer disease
- •The patient is using glucocorticoid at doses >10mg/day.
- •The patient is using sulphasalazine at a dose >3g/day.
- •The patient is using hydroxychloroquine at a dose >400mg/day.
- •The patient is on treatment regimen of DMARDs other than MTX plus one or both of sulphasalazine and hydrochloroquine (e.g. leflunomide)
- •The patient dose of NSAIDs, COX-2 inhibitors or glucocorticoids change at any time during 2 weeks prior to enrolment until the end of the clinical phase of the study
结局指标
主要结局
The primary outcome measure is the values of liver function tests following dosing with methotrexate alone (Day 1) and methotrexate and SB-681323 or placebo (Day 15).
次要结局
- The other comparisons of interest is the pharmacokinetics of methotrexate when dosed alone (Day 1) relative to when dosed with SB681323 (Day 15) pharmacodynamics (effect of SB-681323 on CRP & IL-6 at Days 1, 8 and 15.
研究者
研究点 (3)
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
1 期
A Study To Look At The Safety Of SB-681323 In Healthy Adult Subjects After Intravenous Administration Of A Single DoseArthritis, RheumatoidInflammationNCT00439881GlaxoSmithKline16
已完成
1 期
A Study of LY3007113 in Participants With Advanced CancerMetastatic CancerNCT01463631Eli Lilly and Company27
已完成
2 期
Three Months Treatment With SB683699 In Patients With Relapsing Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingNCT00097331GlaxoSmithKline261
已完成
2 期
SB-681323 In Subjects With Rheumatoid ArthritisArthritis, RheumatoidNCT00320450GlaxoSmithKline78