NCT00729209已完成1 期
A Study of ARRY-371797 in Patients With Rheumatoid Arthritis
Array Biopharma, now a wholly owned subsidiary of Pfizer7 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 7
- 主要终点
- Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
研究概览
简要总结
This is a Phase 1 study, involving a 29-day treatment period, designed to evaluate the pharmacokinetics and the effectiveness of investigational study drug ARRY-371797 in treating rheumatoid arthritis in patients receiving stable doses of methotrexate, and to further evaluate the drug's safety. Approximately 30 patients from the US will be enrolled in this study.
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
- 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
- •Diagnosed with rheumatoid arthritis (RA) at least 3 months prior to study start based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- •On a stable weekly dose of both methotrexate (MTX) (10 - 25 mg/week inclusively; either oral or parenteral) and folate (≥ 5 mg weekly ) for ≥ 6 weeks prior to study start and is willing to continue on these regimens for the duration of the study.
- •Meets the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III.
- •Completed an appropriate washout period if treated with specified therapies.
- •Patients may continue on specified stable background therapy for RA (doses should be stable for at least 6 weeks prior to the first dose of study drug, unless the patient stops due to documented disease improvement, with Sponsor approval).
- •Additional criteria exist.
排除标准
- •Diagnosis of any other inflammatory or non-inflammatory arthritis (e.g. spondyloarthritis; fibromyalgia, psoriatic arthritis, crystal-proven gout) that may interfere with disease activity assessments and/or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
- •Has received any of the following prior treatments:
- •Within 4 weeks of first dose of study drug: anakinra (Kineret®), etanercept (Enbrel®);
- •Within 8 weeks of first dose of study drug: infliximab (Remicade®), adalimumab (Humira®), leflunomide (Arava®);
- •At any time: rituximab (Rituxan®), alemtuzumab (CamPath®), any experimental B cell targeting agents.
- •Treatment with potent CYP3A inhibitors or inducers, disease-modifying antirheumatic drugs (DMARDs) and/or biologic response modifiers (BRMs) during the study.
- •Additional criteria exist.
研究组 & 干预措施
ARRY-371797 (Schedule 1)
Experimental
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
ARRY-371797 (Schedule 2)
Experimental
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
Placebo
Placebo Comparator
干预措施: Placebo; oral (Drug)
结局指标
主要结局
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
时间窗: 29 days
次要结局
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.(29 days)
- Assess the efficacy of study drug (versus placebo) in terms of cross-reactive protein (CRP), the Patient's Assessment of Arthritis Pain (100 mm visual analog scale [VAS]) and urinary N-Telopeptide Cross-Links (NTx).(29 days)
研究者
研究点 (7)
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