NCT00650767已完成2 期
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Array Biopharma, now a wholly owned subsidiary of Pfizer33 个研究点 分布在 7 个国家目标入组 201 人开始时间: 2008年3月最近更新:
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
- 入组人数
- 201
- 试验地点
- 33
- 主要终点
- American College of Rheumatology 20% (ACR20) Response Rate at Week 12
研究概览
简要总结
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania 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
- Treatment
- 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
- •Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
- •Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
- •Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
- •No prior use of biological agents for the treatment of rheumatoid arthritis.
- •Additional criteria exist.
排除标准
- •Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
- •A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
- •Additional criteria exist.
研究组 & 干预措施
ARRY-438162 (Schedule 1)
Experimental
干预措施: ARRY-438162, MEK inhibitor; oral (Drug)
ARRY-438162 (Schedule 2)
Experimental
干预措施: ARRY-438162, MEK inhibitor; oral (Drug)
ARRY-438162 (Schedule 3)
Experimental
干预措施: ARRY-438162, MEK inhibitor; oral (Drug)
Placebo
Placebo Comparator
干预措施: Placebo; oral (Drug)
结局指标
主要结局
American College of Rheumatology 20% (ACR20) Response Rate at Week 12
时间窗: Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
次要结局
- C-Reactive Protein (CRP) at Week 12(Week 12)
- American College of Rheumatology 50% (ACR50) Response Rate at Week 8(Week 8)
- American College of Rheumatology 70% (ACR70) Response Rate at Week 1(Week 1)
- American College of Rheumatology 70% (ACR70) Response Rate at Week 2(Week 2)
- American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)(Week 16 (Follow-up))
- American College of Rheumatology 20% (ACR20) Response Rate at Week 2(Week 2)
- American College of Rheumatology 20% (ACR20) Response Rate at Week 1(Week 1)
- American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)(Week 16 (Follow-up))
- American College of Rheumatology 50% (ACR50) Response Rate at Week 1(Week 1)
- C-Reactive Protein (CRP) at Week 2(Week 2)
- American College of Rheumatology 20% (ACR20) Response Rate at Week 4(Week 4)
- American College of Rheumatology 20% (ACR20) Response Rate at Week 8(Week 8)
- American College of Rheumatology 50% (ACR50) Response Rate at Week 2(Week 2)
- American College of Rheumatology 50% (ACR50) Response Rate at Week 4(Week 4)
- American College of Rheumatology 50% (ACR50) Response Rate at Week 12(Week 12)
- American College of Rheumatology 70% (ACR70) Response Rate at Week 8(Week 8)
- American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)(Week 16 (Follow-up))
- American College of Rheumatology 70% (ACR70) Response Rate at Week 12(Week 12)
- Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)(Week 16 (Follow-up))
- Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)(Week 16 (Follow-up))
- American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)(Week 16 (Follow-up))
- Health Assessment Questionnaire - Disability Index (HAQ-DI)(Week 16 (Follow-up))
- C-Reactive Protein (CRP) at Baseline(Baseline)
- C-Reactive Protein (CRP) at Week 4(Week 4)
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning(Week 16 (Follow-up))
- American College of Rheumatology 70% (ACR70) Response Rate at Week 4(Week 4)
- Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)(Week 16 (Follow-up))
- C-Reactive Protein (CRP) at Week 1(Week 1)
- C-Reactive Protein (CRP) at Week 16 (Follow-up)(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score(Week 16 (Follow-up))
- American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)(Week 16 (Follow-up))
- C-Reactive Protein (CRP) at Week 8(Week 8)
- Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional(Week 16 (Follow-up))
- SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score(Week 16 (Follow-up))
研究者
研究点 (33)
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